Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00310375
• Collaborator: (none)
• Enrollment: 181
• Locations: 51
• Arm: 1
• Actual Duration (Months): 130.5
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name)	Phase 3

Detailed Description

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label, Long-term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-onset Seizures (Extension of Study VRX-RET-E22-301)
• Actual Study Start Date: May 1, 2006
• Actual Primary Completion Date: Nov 30, 2016
• Actual Study Completion Date: Mar 15, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Ezogabine: USAN Retigabine (International Nonproprietary Name) Film-coated tablets - 50mg, 100mg or 300mg

Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name); Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.; Other Names: GKE-841 D-23129 GW582892X

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE) [Assessed up to a maximum of 9 years]

   An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.

2. Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug [Assessed up to a maximum of 9 years]

   Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.

3. Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug [Assessed up to a maximum of 9 years]

   The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn't switch to commercial product were counted as "events". Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title).

4. Change From Baseline in Blood Pressure [Baseline and Up to Month 108]

   Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.

5. Change From Baseline in Heart Rate [Baseline and Up to Month 108]

   Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

6. Change From Baseline in Body Temperature [Baseline and Up to Month 108]

   Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available

7. Change From Baseline in Weight [Baseline and Up to Month 108]

   Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

8. Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF) [Baseline and Up to Month 108]

   A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

9. Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval [Baseline and Up to Month 108]

   A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

10. Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis [Baseline and Up to Month 108]

    A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

11. Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC) [Baseline and Up to Month 108]

    Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

12. Change From Baseline in Hematology Parameter-Red Blood Cell Count [Baseline and Up to Month 108]

    Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..

13. Change From Baseline in Haematocrit [Baseline and Up to Month 108]

    Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

14. Change From Baseline in Haemoglobin [Baseline and Up to Month 108]

    Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..

15. Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) [Baseline and Up to Month 108]

    Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

16. Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea [Baseline and Up to Month 108]

    Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

17. Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA) [Baseline and Up to Month 108]

    Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

18. Change From Baseline in Chemistry Parameter-Total Protein [Baseline and Up to Month 108]

    Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)

19. Change From Baseline in Urine Specific Gravity [Baseline and Up to Month 108]

    Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

20. Change From Baseline in Urine Power of Hydrogen (pH) [Baseline and Up to Month 108]

    Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.

21. Change From Baseline in Post-void Residual Bladder Ultrasound Volume [Baseline and Up to Month 108]

    Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)

22. Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score [Baseline and Up to Month 108]

    An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant's urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)

23. Number of Participants With Abnormal Results in Physical Examination [Up to Month 108]

    A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category

24. Number of Participants With Abnormal Results of Neurological Examination [Up to Month 108]

    Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)

25. Number of Participants With Pigmentation of Non-retinal Ocular Tissue [Assessed up to a maximum of 9 years]

    The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.

26. Number of Participants With Pigmentation of Retinal Ocular Tissue [Assessed up to a maximum of 9 years]

    The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.

27. Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa [Assessed up to a maximum of 9 years]

    An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa

28. Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination [Assessed up to a maximum of 9 years]

    A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.

29. Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination [Assessed up to a maximum of 9 years]

    Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.

30. Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine [2 years and 9 months]

    The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.

31. Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine [2 years 9 months]

    An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.

32. Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation [2 years 9 months]

    Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.

33. Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration [2 years 9 months]

    Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.

Secondary Outcome Measures

1. Percentage Change From Baseline in the 28-day Partial Seizure [Assessed up to a maximum of 9 years]

   Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.

2. Number of Responders [Assessed up to a maximum of 9 years]

   A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.

3. Number of Participants Who Were Seizure Free for Any 6 Continuous Months [Assessed up to a maximum of 9 years]

   Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.

4. Number of Participants Who Were Seizure Free for Any 12 Continuous Months [Assessed up to a maximum of 9 years]

   Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.

5. Percentage of Seizure-free Days [Assessed up to a maximum of 9 years]

   Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days

6. Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire [Assessed up to a maximum of 9 years]

   The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures

• Patient is expected to benefit from participation in the study in the opinion of the Investigator.

Exclusion Criteria:

• Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.

• Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.

• Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama -- Department of Neurology/Epilepsy Center	Birmingham	Alabama	United States	35294
2	North Alabama Neuroscience Research Associates	Huntsville	Alabama	United States	35801
3	Neurology Clinic	Northport	Alabama	United States	35476
4	Barrow Neurological Institute	Phoenix	Arizona	United States	85013
5	Clinical Trials Inc.	Little Rock	Arkansas	United States	72205
6	UCSD Thornton Hospital	La Jolla	California	United States	92037
7	University of Southern California -- Keck School of Medicine	Los Angeles	California	United States	90033
8	West Los Angeles VA Healthcare Center	Los Angeles	California	United States	90073
9	Delta Waves	Colorado Springs	Colorado	United States	80918
10	University of Colorado Department Of Neurology	Denver	Colorado	United States	80010
11	University of Florida -- Shands Jacksonville	Jacksonville	Florida	United States	32209
12	University of Miami	Miami	Florida	United States	33136
13	Lovelace Scientific Resources	Sarasota	Florida	United States	34233
14	McFarland Clinic	Ames	Iowa	United States	50010
15	University of Kentucky	Lexington	Kentucky	United States	40536
16	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland	United States	20817
17	Henry Ford Hospital	Detroit	Michigan	United States	48202
18	Minnesota Epilepsy Group, P.A.	Saint Paul	Minnesota	United States	55102
19	The Comprehensive Epilepsy Care Center for Children and Adults	Chesterfield	Missouri	United States	63017
20	Beth Israel Medical Center	New York	New York	United States	10003
21	Asheville Neurology Specialists	Asheville	North Carolina	United States	28801
22	Medical University of Ohio at Toledo	Toledo	Ohio	United States	43614
23	Oregon Neurology PC	Tualatin	Oregon	United States	97062
24	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
25	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212
26	Medical City Dallas Hospital	Dallas	Texas	United States	75230
27	Neurological Clinic of Texas	Dallas	Texas	United States	75230
28	Memorial Hermann Hospital	Houston	Texas	United States	77030
29	University of Virginia Comprehensive Epilepsy Program	Charlottesville	Virginia	United States	22903
30	Virginia Commonwealth University Medical Center	Richmond	Virginia	United States	23298
31	Hospital Italiano de Buenos Aires	Capital Federal	CBA	Argentina	C1181ACH
32	Hospital General de Agudos "Dr. J.M. Ramos Mejia"	Capital Federal	CBA	Argentina
33	Hospital General de Agudos "Dr. Teodoro Alvarez"	Capital Federal	CBA	Argentina
34	Fundacion Lennox	Cordoba	CRD	Argentina	5000
35	Sanatorio del Salvador II	Cordoba	CRD	Argentina	5000
36	Hospital Privado Centro Medico de Cordoba	Cordoba	CRD	Argentina	X5016KEH
37	Hospital Universitario Prof Edgard Santos -- UFBA	Salvador	BA	Brazil	40110-060
38	Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia	Ribeirao Preto	SP	Brazil	14048-900
39	Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP	Sao Paulo	SP	Brazil	04024 002
40	Hospital das Clinicas da Fac de Medicina de Sao Paulo	Sao Paulo	SP	Brazil	05403-900
41	Foothills Medical Center	Calgary	Alberta	Canada	T2N 2T9
42	Glenrose Rehabilitation Center	Edmonton	Alberta	Canada	T5G 0B7
43	Health Sciences Centre	St. John's	Newfoundland and Labrador	Canada	A1B 3V6
44	CHUM -- Hôpital Notre-Dame	Montréal	Quebec	Canada	H2L 4M1
45	Instituto Nacional de Neurologia y Neurocirugia	La Fama	DF	Mexico	42690
46	Centro Medico	Mexico	DF	Mexico	03229
47	Hospital de Psiquiatria San Fernando, IMSS	Mexico	DF	Mexico	14050
48	CIF BIOTEC, Medica Sur	Tlalpan	DF	Mexico	14050
49	Antiguo Hospital Civil de Guadalajara	Guadalajara	Jalisco	Mexico	44280
50	Hospital y Clinica OCA S.A. de C.V.	Monterrey	Nuevo Leon	Mexico	64000
51	Hospital Central Dr. Ignacio Morones Prieto	San Luis Potosi	SLP	Mexico	78250

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00310375
• Other Study ID Numbers: VRX-RET-E22-303; RTG115098
• First Posted: Apr 3, 2006
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Epilepsy; Partial Seizures; Potassium Channels; Anticonvulsant; Complex Partial Seizures; Epilepsies, Partial; RTG115098
• Additional relevant MeSH terms: Epilepsy; Ezogabine

Study Results

Participant Flow

Recruitment Details	Eligible Participants (Par) who completed the Maintenance and Transition Phases of the parent study were enrolled in this open-label extension study. Par received 600-1200 mg/day retigabine as an adjunct therapy to current antiepileptic medication or vagal nerve stimulation until Par was withdrawn or withdrew consent or until study was terminated.
Pre-assignment Detail	All participants who completed Study VRX-RET-E22-301(parent study) and did not have an ongoing serious adverse event (SAE) were eligible to participate in the study.

Arm/Group Title	Placebo in Parent Study	Retigabine in Parent Study	Safety Follow-up Continuation Phase (SFUCP)
Arm/Group Description	Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.	Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.	Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Period Title: Primary Reporting Phase
STARTED	102	79	0
COMPLETED	11	11	0
NOT COMPLETED	91	68	0
Period Title: Primary Reporting Phase
STARTED	0	0	19
COMPLETED	0	0	18
NOT COMPLETED	0	0	1

Baseline Characteristics

Arm/Group Title	Placebo in Parent Study	Retigabine in Parent Study	Total
Arm/Group Description	Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.	Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.	Total of all reporting groups
Overall Participants	102	79	181
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	38.0 (11.74)	37.1 (12.20)	37.6 (11.92)
Sex: Female, Male (Count of Participants)
Female	55 53.9%	39 49.4%	94 51.9%
Male	47 46.1%	40 50.6%	87 48.1%
Race/Ethnicity, Customized (Number) [Number]
Caucasian	54 52.9%	40 50.6%	94 51.9%
Hispanic	30 29.4%	26 32.9%	56 30.9%
African-American (black)	7 6.9%	7 8.9%	14 7.7%
Other	11 10.8%	6 7.6%	17 9.4%
Number of Participants with Vagal nerve stimulator (VNS) use (Number) [Number]
No	89 87.3%	74 93.7%	163 90.1%
Yes	13 12.7%	5 6.3%	18 9.9%
Number of background AEDs (Number) [Number]
AED=1	12 11.8%	18 22.8%	30 16.6%
AED=2	47 46.1%	41 51.9%	88 48.6%
AED=3	43 42.2%	20 25.3%	63 34.8%
Mean Duration of Partial seizures (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	24.1 (13.06)	23.7 (12.88)	23.9 (12.95)
Mean Duration of Generalized Seizure (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	18.6 (12.45)	25.8 (13.25)	21.5 (12.94)
Clinical Global Impression (CGI) at Baseline (Number) [Number]
Not Assessed	0 0%	0 0%	0 0%
No Seizures	0 0%	0 0%	0 0%
Very Mild Severity	2 2%	0 0%	2 1.1%
Mild Severity	9 8.8%	8 10.1%	17 9.4%
Moderate Severity	49 48%	40 50.6%	89 49.2%
Marked Severity	36 35.3%	26 32.9%	62 34.3%
Very Severe	6 5.9%	5 6.3%	11 6.1%
Among the Most Extremely Severe	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-emergent Serious Adverse Event (SAE) and Adverse Event (AE)
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization (unplanned hospital stay) or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect. Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who took at least 1 dose of study medication

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Any Treatment-emergent SAE	48 47.1%
Any Treatment-emergent AE	173 169.6%

2. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events Leading to Withdrawal From Study Drug
Description	Treatment-emergent AE was defined as an AE with an onset on or after the day of first dose of the study medication and on or before 30 days after the last dose date. AEs reported during parent study and worsened after first dose of RTG in this OLE study were also reported.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Number [Participants.]	52 51%

3. Primary Outcome

Title	Kaplan-Meier Estimate of the Probability of Discontinuation (d/c) From Study Drug
Description	The time frame of premature study discontinuation was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who have a taper dose start date, the time of withdrawal was the day before the start of taper dose. For those without a taper dose start date, the time of withdrawal was the last dose date. Participants who switched to the commercial product were censored at the last dose of study drug in the Kaplan-Meier analysis. All participants who withdrew from study drug prematurely but didn't switch to commercial product were counted as "events". Kaplan-Meier estimate of the probability of discontinuation at the specified time or earlier. Number of Participants continuing on RTG at each time of withdrawal were analyzed (represented as n=X in category title).
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Day 0,n= 181	0.0
Day 2,n= 180	0.6
Day 6,n= 179	1.1
Day 8,n= 178	1.7
Day 12,n= 177	2.2
Day 13,n= 176	2.8
Day 18,n= 175	3.3
Day 20,n= 174	3.9
Day 21,n= 173	4.4
Day 26,n= 172	5.0
Day 27,n= 170	6.1
Day 28,n= 169	6.6
Day 29,n= 168	7.2
Day 30,n= 167	7.7
Day 32,n= 166	8.3
Day 33,n= 164	9.4
Day 39,n= 163	9.9
Day 50,n= 162	10.5
Day 52,n= 161	11.0
Day 55,n= 160	11.6
Day 67,n= 158	12.7
Day 85,n= 157	13.3
Day 89,n= 155	14.4
Day 91,n= 153	15.5
Day 93,n= 152	16.0
Day 96,n= 151	16.6
Day 109,n= 150	17.1
Day 118,n= 149	17.7
Day 119,n= 148	18.2
Day 124,n= 147	18.8
Day 134,n= 146	19.3
Day 135,n= 145	19.9
Day 140,n= 144	20.4
Day 144,n= 143	21.0
Day 166,n= 142	21.5
Day 167,n= 141	22.1
Day 175,n= 140	22.7
Day 179,n= 139	23.2
Day 180,n= 138	23.8
Day 181,n= 137	24.3
Day 182,n= 135	25.4
Day 185,n= 134	26.0
Day 188,n= 133	26.5
Day 207,n= 132	27.1
Day 210,n= 131	27.6
Day 211,n= 130	28.2
Day 213,n= 129	28.7
Day 216,n= 128	29.3
Day 224,n= 127	29.8
Day 231,n= 126	30.4
Day 237,n= 125	30.9
Day 240,n= 124	31.5
Day 253,n= 123	32.0
Day 271,n= 122	32.6
Day 278,n= 121	33.1
Day 280,n= 120	33.7
Day 281,n= 119	34.3
Day 282,n= 118	34.8
Day 303,n= 117	35.4
Day 315,n= 116	35.9
Day 336,n= 114	37.0
Day 338,n= 113	37.6
Day 358,n= 112	38.1
Day 361,n= 111	38.7
Day 362,n= 110	39.2
Day 372,n= 109	39.8
Day 377,n= 108	40.3
Day 392,n= 107	40.9
Day 407,n= 106	41.4
Day 413,n= 105	42.0
Day 477,n= 104	42.5
Day 479,n= 103	43.1
Day 483,n= 102	43.6
Day 489,n= 101	44.2
Day 535,n= 100	44.8
Day 593,n= 99	45.3
Day 602,n= 98	45.9
Day 603,n= 97	46.4
Day 606,n= 96	47.0
Day 609,n= 95	47.5
Day 660,n= 94	48.1
Day 685,n= 93	48.6
Day 722,n= 92	49.2
Day 783,n= 91	49.7
Day 821,n= 90	50.3
Day 843,n= 88	51.4
Day 848,n= 87	51.9
Day 881,n= 86	52.5
Day 959,n= 85	53.0
Day 1076,n= 84	53.6
Day 1080,n= 83	54.1
Day 1084,n= 82	54.7
Day 1090,n= 81	55.2
Day 1119,n= 80	55.8
Day 1146,n= 79	56.4
Day 1196,n= 78	56.9
Day 1210,n= 77	57.5
Day 1225,n= 76	58.0
Day 1322,n= 75	58.6
Day 1326,n= 74	59.1
Day 1338,n= 73	59.7
Day 1339,n= 72	60.2
Day 1407,n= 71	60.8
Day 1429,n= 70	61.3
Day 1520,n= 69	61.9
Day 1561,n= 68	62.4
Day 1563,n= 67	63.0
Day 1619,n= 66	63.0
Day 1645,n= 65	63.0
Day 1655,n= 64	63.0
Day 1656,n= 63	63.0
Day 1673,n= 62	63.6
Day 1676,n= 61	64.2
Day 1686,n= 60	64.7
Day 1737,n= 59	64.7
Day 1780,n= 58	64.7
Day 1800,n= 57	65.4
Day 1811,n= 56	66.0
Day 1813,n= 55	66.6
Day 1862,n= 54	66.6
Day 1885,n= 53	67.2
Day 1911,n= 52	67.2
Day 1926,n= 51	67.2
Day 1933,n= 50	67.2
Day 1952,n= 49	67.8
Day 1989,n= 48	67.8
Day 1994,n= 47	68.5
Day 2008,n= 46	68.5
Day 2038,n= 45	68.5
Day 2044,n= 44	69.2
Day 2051,n= 43	69.9
Day 2073,n= 42	69.9
Day 2109,n= 41	69.9
Day 2111,n= 40	69.9
Day 2139,n= 39	69.9
Day 2157,n= 38	69.9
Day 2161,n= 37	70.7
Day 2164,n= 36	71.5
Day 2170,n= 35	72.3
Day 2228,n= 34	72.3
Day 2234,n= 33	72.3
Day 2248,n= 32	72.3
Day 2274,n= 31	73.2
Day 2278,n= 30	73.2
Day 2282,n= 28	74.9
Day 2290,n= 27	75.8
Day 2294,n= 26	76.7
Day 2297,n= 25	77.6
Day 2301,n= 24	78.5
Day 2337,n= 23	79.4
Day 2393,n= 22	80.3
Day 2523,n= 21	81.2
Day 2527,n= 20	82.1
Day 2528,n= 19	83.0
Day 2535,n= 18	83.9
Day 2646,n= 16	85.7
Day 2702,n= 15	86.6
Day 2735,n= 14	87.5
Day 2768,n= 13	88.4
Day 2792,n= 12	89.3
Day 2795,n= 11	90.2
Day 2833,n= 10	91.1
Day 2848,n= 9	91.9
Day 2871,n= 8	92.8
Day 2886,n= 7	93.7
Day 3001,n= 6	94.6
Day 3004,n= 5	95.5
Day 3023,n= 4	96.4
Day 3091,n= 3	97.3
Day 3092,n= 2	98.2
Day 3101,n= 1	99.1
Day 3186,n= 0	100.0

4. Primary Outcome

Title	Change From Baseline in Blood Pressure
Description	Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was obtained in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Not Applicable (NA) indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description
Measure Participants	181
Su DBP Mon 1, n=173	-1.1 (9.74)
Su DBP Mon 3, n=159	-0.7 (9.73)
Su DBP Mon 6, n=143	-2.9 (10.61)
Su DBP Mon 9, n=125	-2.6 (10.72)
Su DBP Mon 12, n=173	-0.6 (11.08)
Su DBP Mon 16, n=104	-2.3 (11.69)
Su DBP Mon 20, n=100	-1.9 (13.12)
Su DBP Mon 24, n=112	-1.3 (11.24)
Su DBP Mon 28, n=88	-0.8 (12.75)
Su DBP Mon 32, n=85	-0.6 (11.18)
Su DBP Mon 36, n=92	-1.6 (10.81)
Su DBP Mon 40, n=78	-2.5 (11.62)
Su DBP Mon 44, n=76	-1.1 (11.75)
Su DBP Mon 48, n=82	-1.2 (11.76)
Su DBP Mon 52, n=68	0.7 (9.74)
Su DBP Mon 56, n=63	-0.3 (11.37)
Su DBP Mon 60, n=70	-0.8 (11.67)
Su DBP Mon 64, n=50	-1.7 (11.34)
Su DBP Mon 68, n=45	-1.1 (11.24)
Su DBP Mon 72, n=57	0.2 (11.02)
Su DBP Mon 76, n=31	-0.5 (9.01)
Su DBP Mon 80, n=24	-1 (7.13)
Su DBP Mon 84, n=36	-2.3 (11.04)
Su DBP Mon 88, n=17	-0.1 (6.94)
Su DBP Mon 92, n=16	-2.8 (8.49)
Su DBP Mon 96, n=19	-0.2 (8.3)
Su DBP Mon 100, n=7	-6.3 (3.25)
Su DBP Mon 104, n=1	-20.0 (NA)
Su DBP Mon 108, n=10	-2.0 (7.27)
St DBP Mon 1, n=173	-0.5 (9.97)
St DBP Mon 3, n=159	-1.0 (11.68)
St DBP Mon 6, n=143	-1.8 (11.47)
St DBP Mon 9, n=125	-1.9 (10.17)
St DBP Mon 12, n=170	-1.0 (11.18)
St DBP Mon 16, n=104	-1.8 (11.14)
St DBP Mon 20, n=100	-1.0 (12.02)
St DBP Mon 24, n=110	0.5 (11.78)
St DBP Mon 28, n=87	-1.0 (12.83)
St DBP Mon 32, n=84	0.9 (11.95)
St DBP Mon 36, n=91	-0.7 (10.78)
St DBP Mon 40, n=77	-0.6 (11.09)
St DBP Mon 44, n=75	-0.6 (11.67)
St DBP Mon 48, n=81	0.1 (11.74)
St DBP Mon 52, n=67	1.0 (11.49)
St DBP Mon 56, n=62	-1.0 (11.2)
St DBP Mon 60, n=69	-1.9 (14.12)
St DBP Mon 64, n=49	-2.1 (11.94)
St DBP Mon 68, n=45	-2.9 (11.91)
St DBP Mon 72, n=56	0.5 (11.13)
St DBP Mon 76, n=30	-2.4 (13.08)
St DBP Mon 80, n=23	-2.0 (10.86)
St DBP Mon 84, n=34	-0.6 (12.17)
St DBP Mon 88, n=17	0.6 (8.99)
St DBP Mon 92, n=16	-3.1 (9.84)
St DBP Mon 96, n=19	2.3 (8.81)
St DBP Mon 100, n=7	-4.9 (4.41)
St DBP Mon 104, n=1	-20.0 (NA)
St DBP Mon 108, n=10	-4.5 (5.46)
Su SBP Mon 1, n=173	-1.1 (14.70)
Su SBP Mon 3, n=159	0.3 (12.96)
Su SBP Mon 6, n=143	-0.7 (14.78)
Su SBP Mon 9, n=125	-0.4 (14.14)
Su SBP Mon 12, n=173	0.4 (15.70)
Su SBP Mon 16, n=104	-2.2 (15.08)
Su SBP Mon 20, n=100	-0.7 (15.62)
Su SBP Mon 24, n=112	0.5 (16.11)
Su SBP Mon 28, n=88	-0.1 (16.06)
Su SBP Mon 32, n=85	0.3 (16.57)
Su SBP Mon 36, n=92	0.3 (15.78)
Su SBP Mon 40, n=78	-0.8 (15.08)
Su SBP Mon 44, n=76	0.3 (16.62)
Su SBP Mon 48, n=82	2.6 (15.99)
Su SBP Mon 52, n=68	3.3 (15.32)
Su SBP Mon 56, n=63	1.3 (15.30)
Su SBP Mon 60, n=70	0.7 (13.57)
Su SBP Mon 64, n=50	0.1 (18.76)
Su SBP Mon 68, n=45	-0.2 (18.29)
Su SBP Mon 72, n=57	0.8 (17.21)
Su SBP Mon 76, n=31	-1.2 (17.42)
Su SBP Mon 80, n=24	-2.6 (12.80)
Su SBP Mon 84, n=36	-3.0 (18.16)
Su SBP Mon 88, n=17	0.6 (12.07)
Su SBP Mon 92, n=16	-0.9 (17.07)
Su SBP Mon 96, n=19	-0.9 (12.33)
Su SBP Mon 100, n=7	-3.6 (9.95)
Su SBP Mon 104, n=1	-20.0 (NA)
Su SBP Mon 108, n=10	-4.4 (16.60)
St SBP Mon 1, n=173	0.3 (14.10)
St SBP Mon 3, n=159	-1.6 (15.38)
St SBP Mon 6, n=143	0.1 (14.35)
St SBP Mon 9, n=125	0.2 (14.84)
St SBP Mon 12, n=170	1.4 (15.25)
St SBP Mon 16, n=104	0.1 (14.69)
St SBP Mon 20, n=100	2.1 (16.05)
St SBP Mon 24, n=110	3.8 (17.42)
St SBP Mon 28, n=87	1.6 (15.53)
St SBP Mon 32, n=84	3.1 (17.06)
St SBP Mon 36, n=91	1.7 (15.20)
St SBP Mon 40, n=77	1.7 (16.79)
St SBP Mon 44, n=75	2.7 (15.80)
St SBP Mon 48, n=81	3.3 (14.51)
St SBP Mon 52, n=67	3.9 (18.37)
St SBP Mon 56, n=62	2.7 (13.99)
St SBP Mon 60, n=69	2.1 (13.41)
St SBP Mon 64, n=49	2.4 (17.27)
St SBP Mon 68, n=45	-0.3 (15.98)
St SBP Mon 72, n=56	2.3 (17.23)
St SBP Mon 76, n=30	-4.5 (17.63)
St SBP Mon 80, n=23	-1.1 (13.70)
St SBP Mon 84, n=34	-1.9 (13.46)
St SBP Mon 88, n=17	2.1 (11.89)
St SBP Mon 92, n=16	-4.9 (14.38)
St SBP Mon 96, n=19	0.5 (12.24)
St SBP Mon 100, n=7	-4.6 (11.16)
St SBP Mon 104, n=1	-22.0 (NA)
St SBP Mon 108, n=10	-5.5 (7.14)

5. Primary Outcome

Title	Change From Baseline in Heart Rate
Description	Heart rate (HR) was measured in supine (Su) position and again in standing (St) position after the participant was standing for approximately 2 minutes at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Su HR Mon 1, n=174	-1.0 (10.21)
Su HR Mon 3, n=159	-0.7 (11.34)
Su HR Mon 6, n=143	-0.2 (11.57)
Su HR Mon 9, n=124	-1.0 (11.33)
Su HR Mon 12, n=173	-0.1 (12.02)
Su HR Mon 16, n=104	1.1 (12.51)
Su HR Mon 20, n=100	1.1 (12.10)
Su HR Mon 24, n=112	-0.1 (15.92)
Su HR Mon 28, n=88	-0.8 (13.11)
Su HR Mon 32, n=85	0.4 (12.56)
Su HR Mon 36, n=92	-1.7 (11.38)
Su HR Mon 40, n=78	-0.6 (13.28)
Su HR Mon 44, n=76	-2.8 (12.47)
Su HR Mon 48, n=82	-2.1 (11.25)
Su HR Mon 52, n=67	-1.5 (11.39)
Su HR Mon 56, n=63	-1.8 (12.30)
Su HR Mon 60, n=70	-1.2 (12.89)
Su HR Mon 64, n=50	-2.1 (11.54)
Su HR Mon 68, n=45	1.2 (13.87)
Su HR Mon 72, n=57	-1.9 (12.32)
Su HR Mon 76, n=31	-1.6 (13.05)
Su HR Mon 80, n=24	-2.2 (11.93)
Su HR Mon 84, n=36	-2.4 (12.56)
Su HR Mon 88, n=17	1.5 (13.98)
Su HR Mon 92, n=16	-2.7 (11.52)
Su HR Mon 96, n=19	-1.0 (14.35)
Su HR Mon 100, n=7	-8.3 (19.10)
Su HR Mon 104, n=1	-6.0 (NA)
Su HR Mon 108, n=10	-3.4 (12.86)
St HR Mon 1, n=174	0.7 (11.97)
St HR Mon 3, n=158	1.0 (12.02)
St HR Mon 6, n=143	1.6 (12.82)
St HR Mon 9, n=124	1.1 (12.99)
St HR Mon 12, n=170	2.3 (12.64)
St HR Mon 16, n=104	2.5 (12.71)
St HR Mon 20, n=100	0.2 (13.35)
St HR Mon 24, n=110	2.6 (17.38)
St HR Mon 28, n=87	-0.8 (13.79)
St HR Mon 32, n=84	1.7 (11.71)
St HR Mon 36, n=91	-0.4 (12.40)
St HR Mon 40, n=77	0.4 (11.51)
St HR Mon 44, n=75	-0.3 (12.74)
St HR Mon 48, n=81	-1.9 (12.57)
St HR Mon 52, n=67	-0.3 (12.71)
St HR Mon 56, n=62	1.3 (12.21)
St HR Mon 60, n=69	-0.2 (14.44)
St HR Mon 64, n=49	1.3 (14.29)
St HR Mon 68, n=45	4.1 (14.77)
St HR Mon 72, n=56	0.4 (12.10)
St HR Mon 76, n=30	1.9 (13.26)
St HR Mon 80, n=23	3.0 (11.81)
St HR Mon 84, n=35	0.2 (13.24)
St HR Mon 88, n=17	3.6 (12.24)
St HR Mon 92, n=16	3.1 (10.13)
St HR Mon 96, n=19	3.2 (13.12)
St HR Mon 100, n=7	2.6 (10.72)
St HR Mon 104, n=1	0.0 (NA)
St HR Mon 108, n=10	-5.4 (11.37)

6. Primary Outcome

Title	Change From Baseline in Body Temperature
Description	Body temperature was measured in degree Celsius at each study visit (Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Temperature, Mon 1, n=174	-0.04 (0.437)
Temperature, Mon 3, n=158	-0.08 (0.460)
Temperature, Mon 6, n=142	-0.05 (0.455)
Temperature, Mon 9, n=124	-0.06 (0.479)
Temperature, Mon 12, n=172	-0.07 (0.489)
Temperature, Mon 16, n=102	-0.01 (0.477)
Temperature, Mon 20, n=98	-0.00 (0.495)
Temperature, Mon 24, n=110	-0.07 (0.532)
Temperature, Mon 28, n=86	-0.08 (0.457)
Temperature, Mon 32, n=85	-0.09 (0.456)
Temperature, Mon 36, n=92	-0.13 (0.543)
Temperature, Mon 40, n=77	-0.12 (0.492)
Temperature, Mon 44, n=76	-0.07 (0.523)
Temperature, Mon 48, n=82	-0.06 (0.525)
Temperature, Mon 52, n=68	-0.13 (0.439)
Temperature, Mon 56, n=63	-0.09 (0.566)
Temperature, Mon 60, n=70	-0.02 (0.436)
Temperature, Mon 64, n=48	-0.12 (0.451)
Temperature, Mon 68, n=45	-0.01 (0.497)
Temperature, Mon 72, n=57	-0.06 (0.433)
Temperature, Mon 76, n=31	-0.04 (0.506)
Temperature, Mon 80, n=24	-0.08 (0.472)
Temperature, Mon 84, n=36	-0.19 (0.481)
Temperature, Mon 88, n=17	-0.20 (0.496)
Temperature, Mon 92, n=16	-0.14 (0.542)
Temperature, Mon 96, n=19	-0.26 (0.512)
Temperature, Mon 100, n=7	-0.14 (0.690)
Temperature, Mon 104, n=1	1.00 (NA)
Temperature, Mon 108, n=10	-0.15 (0.645)

7. Primary Outcome

Title	Change From Baseline in Weight
Description	Weight was measured in ordinary indoor clothing (without shoes) and was recorded at each study visit (On Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Weight, Mon 1, n=172	1.94 (3.691)
Weight, Mon 3, n=159	1.85 (6.455)
Weight, Mon 6, n=143	1.68 (5.315)
Weight, Mon 9, n=123	1.57 (6.149)
Weight, Mon 12, n=171	1.31 (6.961)
Weight, Mon 16, n=104	2.17 (8.799)
Weight, Mon 20, n=101	1.62 (7.786)
Weight, Mon 24, n=111	1.21 (8.178)
Weight, Mon 28, n=88	0.35 (8.859)
Weight, Mon 32, n=85	0.07 (9.084)
Weight, Mon 36, n=92	0.61 (8.066)
Weight, Mon 40, n=78	0.84 (9.106)
Weight, Mon 44, n=76	0.88 (8.137)
Weight, Mon 48, n=82	0.73 (9.097)
Weight, Mon 52, n=68	1.10 (9.401)
Weight, Mon 56, n=62	1.28 (8.998)
Weight, Mon 60, n=69	0.94 (9.335)
Weight, Mon 64, n=49	2.13 (10.004)
Weight, Mon 68, n=44	2.77 (9.79)
Weight, Mon 72, n=57	0.85 (10.701)
Weight, Mon 76, n=31	3.30 (8.260)
Weight, Mon 80, n=24	1.48 (7.899)
Weight, Mon 84, n=36	2.47 (10.022)
Weight, Mon 88, n=17	1.45 (9.036)
Weight, Mon 92, n=16	1.64 (7.571)
Weight, Mon 96, n=19	0.48 (9.380)
Weight, Mon 100, n=7	4.31 (7.006)
Weight, Mon 104, n=1	2.10 (NA)
Weight, Mon 108, n=10	3.18 (5.743)

8. Primary Outcome

Title	Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameters-PR Interval, QRS Duration, Uncorrected QT (uQT) Interval, Corrected QT (Bazett's Correction) Interval (QTcB), Corrected QT (Friedericia's Correction) Interval (QTcF)
Description	A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented PR Interval, QRS Duration, Uncorrected QT interval (uQT), Corrected QT (Bazett's correction) interval (QTcB), Corrected QT (Friedericia's correction) interval (QTcF). Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
QTcB, Mon 1, n=172	3.3 (18.13)
QTcB, Mon 3, n=157	5.8 (18.84)
QTcB, Mon 6, n=139	1.5 (17.29)
QTcB, Mon 9, n=121	2.2 (17.18)
QTcB, Mon 12, n=168	5.7 (19.18)
QTcB, Mon 24, n=109	5.9 (18.52)
QTcB, Mon 36, n=89	3.7 (20.32)
QTcB, Mon 48, n=80	5.4 (17.74)
QTcB, Mon 60, n=70	5.1 (17.76)
QTcB, Mon 72, n=54	5.5 (15.86)
QTcB, Mon 84, n=36	8.1 (16.02)
QTcB, Mon 96, n=19	11.0 (15.95)
QTcB, Mon 108, n=10	-3.7 (17.25)
QTcF, Mon 1, n=172	4.7 (16.12)
QTcF, Mon 3, n=157	6.0 (16.57)
QTcF, Mon 6, n=139	1.4 (15.79)
QTcF, Mon 9, n=121	2.9 (15.57)
QTcF, Mon 12, n=168	5.5 (16.51)
QTcF, Mon 24, n=109	4.7 (15.91)
QTcF, Mon 36, n=89	4.3 (16.58)
QTcF, Mon 48, n=80	5.9 (14.93)
QTcF, Mon 60, n=70	5.9 (13.94)
QTcF, Mon 72, n=54	7.2 (16.89)
QTcF, Mon 84, n=36	9.3 (14.20)
QTcF, Mon 96, n=19	8.9 (14.83)
QTcF, Mon 108, n=10	-5.7 (12.64)
PR interval, Mon 1, n=173	-0.8 (13.07)
PR interval, Mon 3, n=158	1.0 (12.99)
PR interval, Mon 6, n=139	0.0 (12.69)
PR interval, Mon 9, n=123	-1.4 (12.44)
PR interval, Mon 12, n=168	-1.0 (12.61)
PR interval, Mon 24, n=110	-3.1 (12.16)
PR interval, Mon 36, n=89	-0.3 (11.39)
PR interval, Mon 48, n=80	0.3 (16.32)
PR interval, Mon 60, n=71	2.5 (14.12)
PR interval, Mon 72, n=53	2.2 (11.71)
PR interval, Mon 84, n=36	4.3 (9.34)
PR interval, Mon 96, n=19	-2.4 (13)
PR interval, Mon 108, n=10	0.0 (15.5)
QRS duration, Mon 1, n=174	0.4 (7.37)
QRS duration, Mon 3, n=159	-0.2 (7.64)
QRS duration, Mon 6, n=142	-0.2 (7.05)
QRS duration, Mon 9, n=124	0.4 (8.04)
QRS duration, Mon 12, n=171	-0.0 (9.4)
QRS duration, Mon 24, n=112	0.7 (8.56)
QRS duration, Mon 36, n=90	1.6 (7.31)
QRS duration, Mon 48, n=81	4.0 (7.82)
QRS duration, Mon 60, n=70	3.9 (8.19)
QRS duration, Mon 72, n=55	6.2 (9.15)
QRS duration, Mon 84, n=36	4.2 (7.94)
QRS duration, Mon 96, n=19	3.8 (7.21)
QRS duration, Mon 108, n=10	3.7 (9.4)
uQT, Mon 1, n=172	7.5 (22.93)
uQT, Mon 3, n=157	6.4 (25.31)
uQT, Mon 6, n=139	1.4 (25.95)
uQT, Mon 9, n=121	4.3 (25.00)
uQT, Mon 12, n=168	5.1 (24.70)
uQT, Mon 24, n=109	2.8 (23.97)
uQT, Mon 36, n=89	5.5 (22.57)
uQT, Mon 48, n=80	7.2 (22.42)
uQT, Mon 60, n=70	7.3 (24.74)
uQT, Mon 72, n=54	11.0 (28.33)
uQT, Mon 84, n=36	12.5 (26.56)
uQT, Mon 96, n=19	5.4 (26.73)
uQT, Mon 108, n=10	-8.7 (14.01)

9. Primary Outcome

Title	Change From Baseline in the 12-lead Electrocardiogram (ECG) Parameter-RR Interval
Description	A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. The following electrocardiogram parameters are presented: RR Interval. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
RR interval, Mon 1, n=174	0.0195 (0.11576)
RR interval, Mon 3, n=159	0.0029 (0.12883)
RR interval, Mon 6, n=142	-0.0007 (0.13151)
RR interval, Mon 9, n=124	0.0103 (0.12659)
RR interval, Mon 12, n=172	-0.0015 (0.12556)
RR interval, Mon 24, n=112	-0.0119 (0.1206)
RR interval, Mon 36, n=92	0.0144 (0.12476)
RR interval, Mon 48, n=81	0.0145 (0.12175)
RR interval, Mon 60, n=71	0.0098 (0.14452)
RR interval, Mon 72, n=55	0.0251 (0.12713)
RR interval, Mon 84, n=36	0.0285 (0.15006)
RR interval, Mon 96, n=19	-0.0237 (0.1485)
RR interval, Mon 108, n=10	-0.0173 (0.10885)

10. Primary Outcome

Title	Change From Baseline in Electrocardiogram (ECG) Parameter-QRS Axis
Description	A 12-lead ECG was performed at each study visit during the first year of the study (Month 1, Month 3, Month 6, Month 9, Month 12) and annually after one year. ECG parameter QRS Axis is presented here. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
QRS axis, Mon 1, n=167	-1.3 (14.34)
QRS axis, Mon 3, n=151	-2.9 (15.94)
QRS axis, Mon 6, n=134	-1.5 (11.50)
QRS axis, Mon 9, n=118	-2.3 (11.8)
QRS axis, Mon 12, n=160	-3.1 (13.72)
QRS axis, Mon 24, n=104	-1.9 (13.03)
QRS axis, Mon 36, n=87	-2.5 (11.43)
QRS axis, Mon 48, n=77	-3.4 (19.82)
QRS axis, Mon 60, n=68	-8.0 (14.50)
QRS axis, Mon 72, n=52	-4.0 (12.31)
QRS axis, Mon 84, n=34	-4.1 (16.09)
QRS axis, Mon 96, n=18	-4.9 (8.53)
QRS axis, Mon 108, n=10	-7.0 (8.81)

11. Primary Outcome

Title	Change From Baseline in Hematology Parameters- Bands, Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets, White Blood Cells Count (WBC)
Description	Following hematology parameters were assessed, Bands (Band neutrophils), Basophils, Eosinophils, Lymphocytes, Metamyelocyte, Monocytes, Neutrophils, Platelets and WBC. Hematology parameters were assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Bands, Mon 1, n=2	-0.135 (0.1768)
Bands, Mon 9, n=2	-0.205 (0.6576)
Bands, Mon 20, n=2	-0.095 (0.1202)
Basophils, Mon 1, n=168	-0.001 (0.0270)
Basophils, Mon 2, n=15	-0.015 (0.0307)
Basophils, Mon 3, n=153	0.001 (0.0274)
Basophils, Mon 4, n=26	-0.002 (0.0199)
Basophils, Mon 6, n=137	0.004 (0.0245)
Basophils, Mon 8, n=42	0.002 (0.0258)
Basophils, Mon 9, n=121	0.003 (0.0274)
Basophils, Mon 10, n=54	0.001 (0.0241)
Basophils, Mon 12, n=165	0.001 (0.0298)
Basophils, Mon 16, n=96	0.005 (0.0288)
Basophils, Mon 20, n=92	0.004 (0.0271)
Basophils, Mon 24, n=109	0.008 (0.0289)
Basophils, Mon 28, n=84	0.005 (0.0289)
Basophils, Mon 32, n=81	0.005 (0.0301)
Basophils, Mon 36, n=91	0.006 (0.0295)
Basophils, Mon 40, n=74	0.004 (0.0243)
Basophils, Mon 44, n=72	0.004 (0.0200)
Basophils, Mon 48, n=77	0.004 (0.0313)
Basophils, Mon 52, n=65	-0.004 (0.0227)
Basophils, Mon 56, n=63	-0.004 (0.0234)
Basophils, Mon 60, n=71	-0.003 (0.0238)
Basophils, Mon 64, n=49	-0.003 (0.0195)
Basophils, Mon 68, n=43	0.001 (0.0197)
Basophils, Mon 72, n=53	-0.003 (0.0227)
Basophils, Mon 76, n=31	-0.000 (0.0218)
Basophils, Mon 80, n=24	-0.001 (0.0198)
Basophils, Mon 84, n=33	0.002 (0.0238)
Basophils, Mon 88, n=16	0.003 (0.0202)
Basophils, Mon 92, n=15	0.005 (0.0288)
Basophils, Mon 96, n=19	0.006 (0.0257)
Basophils, Mon 100, n=7	0.021 (0.0157)
Basophils, Mon 104, n=1	-0.020 (NA)
Basophils, Mon 108, n=10	0.012 (0.0210)
Eosinophils, Mon 1, n=168	-0.008 (0.1009)
Eosinophils, Mon 2, n=15	0.023 (0.0948)
Eosinophils, Mon 3, n=153	-0.010 (0.1329)
Eosinophils, Mon 4, n=26	-0.003 (0.1236)
Eosinophils, Mon 6, n=137	-0.015 (0.1208)
Eosinophils, Mon 8, n=42	-0.022 (0.1078)
Eosinophils, Mon 9, n=121	-0.010 (0.1166)
Eosinophils, Mon 10, n=54	0.000 (0.1083)
Eosinophils, Mon 12, n=165	-0.019 (0.0943)
Eosinophils, Mon 16, n=96	-0.006 (0.1145)
Eosinophils, Mon 20, n=92	-0.009 (0.0941)
Eosinophils, Mon 24, n=109	-0.002 (0.1108)
Eosinophils, Mon 28, n=84	-0.016 (0.1114)
Eosinophils, Mon 32, n=81	0.001 (0.1192)
Eosinophils, Mon 36, n=91	-0.006 (0.1026)
Eosinophils, Mon 40, n=74	-0.004 (0.1165)
Eosinophils, Mon 44, n=72	-0.014 (0.1158)
Eosinophils, Mon 48, n=77	-0.002 (0.1230)
Eosinophils, Mon 52, n=65	-0.011 (0.1137)
Eosinophils, Mon 56, n=63	-0.002 (0.1251)
Eosinophils, Mon 60, n=71	-0.014 (0.1123)
Eosinophils, Mon 64, n=49	-0.008 (0.0989)
Eosinophils, Mon 68, n=43	-0.000 (0.1122)
Eosinophils, Mon 72, n=53	0.005 (0.1049)
Eosinophils, Mon 76, n=31	-0.003 (0.1102)
Eosinophils, Mon 80, n=24	-0.010 (0.0837)
Eosinophils, Mon 84, n=33	-0.000 (0.1105)
Eosinophils, Mon 88, n=16	0.030 (0.0602)
Eosinophils, Mon 92, n=15	0.006 (0.0631)
Eosinophils, Mon 96, n=19	0.018 (0.0511)
Eosinophils, Mon 100, n=7	0.033 (0.093)
Eosinophils, Mon 104, n=1	0.030 (NA)
Eosinophils, Mon 108, n=10	-0.005 (0.0792)
Lymphocytes, Mon 1, n=168	-0.178 (0.4512)
Lymphocytes, Mon 2, n=15	-0.043 (0.6364)
Lymphocytes, Mon 3, n=153	-0.134 (0.4336)
Lymphocytes, Mon 4, n=26	0.054 (0.3529)
Lymphocytes, Mon 6, n=137	-0.055 (0.4415)
Lymphocytes, Mon 8, n=42	0.168 (0.7157)
Lymphocytes, Mon 9, n=121	-0.031 (0.472)
Lymphocytes, Mon 10, n=54	0.120 (0.5265)
Lymphocytes, Mon 12, n=165	0.009 (0.5438)
Lymphocytes, Mon 16, n=96	-0.053 (0.5393)
Lymphocytes, Mon 20, n=92	-0.031 (0.5364)
Lymphocytes, Mon 24, n=109	-0.069 (0.4973)
Lymphocytes, Mon 28, n=84	-0.077 (0.5271)
Lymphocytes, Mon 32, n=81	0.013 (0.5920)
Lymphocytes, Mon 36, n=91	-0.055 (0.4798)
Lymphocytes, Mon 40, n=74	-0.028 (0.4699)
Lymphocytes, Mon 44, n=72	0.008 (0.4681)
Lymphocytes, Mon 48, n=77	0.061 (0.5921)
Lymphocytes, Mon 52, n=65	-0.049 (0.4875)
Lymphocytes, Mon 56, n=63	-0.065 (0.5298)
Lymphocytes, Mon 60, n=71	-0.025 (0.5503)
Lymphocytes, Mon 64, n=49	-0.011 (0.5106)
Lymphocytes, Mon 68, n=43	-0.002 (0.6027)
Lymphocytes, Mon 72, n=53	-0.052 (0.5410)
Lymphocytes, Mon 76, n=31	0.104 (0.6589)
Lymphocytes, Mon 80, n=24	0.149 (0.6626)
Lymphocytes, Mon 84, n=33	0.154 (0.6009)
Lymphocytes, Mon 88, n=16	0.189 (0.4887)
Lymphocytes, Mon 92, n=15	0.405 (0.5963)
Lymphocytes, Mon 96, n=19	0.285 (0.6170)
Lymphocytes, Mon 100, n=7	0.144 (0.4465)
Lymphocytes, Mon 104, n=1	0.000 (NA)
Lymphocytes, Mon 108, n=10	0.044 (0.5883)
Metamyelocyte, Mon 3, n=1	-0.010 (NA)
Monocytes, Mon 1, n=168	0.006 (0.1755)
Monocytes, Mon 2, n=15	0.002 (0.2583)
Monocytes, Mon 3, n=153	0.016 (0.1730)
Monocytes, Mon 4, n=26	0.039 (0.1759)
Monocytes, Mon 6, n=137	-0.001 (0.1628)
Monocytes, Mon 8, n=42	0.033 (0.2000)
Monocytes, Mon 9, n=121	-0.002 (0.1808)
Monocytes, Mon 10, n=54	0.029 (0.1686)
Monocytes, Mon 12, n=165	-0.007 (0.1724)
Monocytes, Mon 16, n=96	-0.021 (0.1651)
Monocytes, Mon 20, n=92	-0.009 (0.1573)
Monocytes, Mon 24, n=109	-0.004 (0.2189)
Monocytes, Mon 28, n=84	-0.031 (0.1759)
Monocytes, Mon 32, n=81	-0.005 (0.1673)
Monocytes, Mon 36, n=91	-0.039 (0.1821)
Monocytes, Mon 40, n=74	-0.013 (0.1718)
Monocytes, Mon 44, n=72	-0.037 (0.1807)
Monocytes, Mon 48, n=77	-0.036 (0.1869)
Monocytes, Mon 52, n=65	-0.026 (0.1743)
Monocytes, Mon 56, n=63	-0.035 (0.1776)
Monocytes, Mon 60, n=71	-0.013 (0.1720)
Monocytes, Mon 64, n=49	-0.024 (0.1486)
Monocytes, Mon 68, n=43	0.003 (0.1491)
Monocytes, Mon 72, n=53	-0.007 (0.1704)
Monocytes, Mon 76, n=31	0.038 (0.1456)
Monocytes, Mon 80, n=24	0.019 (0.1473)
Monocytes, Mon 84, n=33	0.065 (0.1555)
Monocytes, Mon 88, n=16	-0.006 (0.1699)
Monocytes, Mon 92, n=15	0.029 (0.1737)
Monocytes, Mon 96, n=19	0.035 (0.1437)
Monocytes, Mon 100, n=7	0.004 (0.1274)
Monocytes, Mon 104, n=1	0.070 (NA)
Monocytes, Mon 108, n=10	0.064 (0.2400)
Neutrophils, Mon 1, n=168	0.158 (1.5462)
Neutrophils, Mon 2, n=15	-0.500 (1.6917)
Neutrophils, Mon 3, n=153	0.211 (1.2173)
Neutrophils, Mon 4, n=26	-0.003 (1.1181)
Neutrophils, Mon 6, n=137	0.124 (1.0916)
Neutrophils, Mon 8, n=42	-0.427 (1.1287)
Neutrophils, Mon 9, n=121	0.074 (1.0966)
Neutrophils, Mon 10, n=54	0.211 (1.4455)
Neutrophils, Mon 12, n=165	0.309 (1.2657)
Neutrophils, Mon 16, n=96	0.232 (1.0227)
Neutrophils, Mon 20, n=92	0.145 (1.039)
Neutrophils, Mon 24, n=109	0.221 (1.1556)
Neutrophils, Mon 28, n=84	-0.032 (1.1173)
Neutrophils, Mon 32, n=81	-0.034 (1.1604)
Neutrophils, Mon 36, n=91	-0.054 (1.0499)
Neutrophils, Mon 40, n=74	0.141 (1.101)
Neutrophils, Mon 44, n=72	0.003 (1.0641)
Neutrophils, Mon 48, n=77	0.197 (1.4174)
Neutrophils, Mon 56, n=63	0.075 (1.069)
Neutrophils, Mon 52, n=65	0.151 (1.1449)
Neutrophils, Mon 60, n=71	0.203 (1.653)
Neutrophils, Mon 64, n=49	-0.042 (1.0603)
Neutrophils, Mon 68, n=43	0.304 (1.3417)
Neutrophils, Mon 72, n=53	0.337 (1.3877)
Neutrophils, Mon 76, n=31	0.380 (0.9556)
Neutrophils, Mon 80, n=24	0.495 (1.1337)
Neutrophils, Mon 84, n=33	0.735 (1.2746)
Neutrophils, Mon 88, n=16	0.036 (0.689)
Neutrophils, Mon 92, n=15	0.275 (1.2747)
Neutrophils, Mon 96, n=19	0.444 (1.1230)
Neutrophils, Mon 100, n=7	0.156 (0.5022)
Neutrophils, Mon 104, n=1	0.270 (NA)
Neutrophils, Mon 108, n=10	0.185 (0.9415)
Platelet Count, Mon 1, n=165	-4.1 (38.59)
Platelet Count, Mon 2, n=15	5.3 (47.49)
Platelet Count, Mon 3, n=150	-5.4 (40.70)
Platelet Count, Mon 4, n=26	-2 (54.42)
Platelet Count, Mon 6, n=131	-7 (48.59)
Platelet Count, Mon 8, n=42	6 (49.17)
Platelet Count, Mon 9, n=119	-4.7 (38.65)
Platelet Count, Mon 10, n=54	2.9 (39.60)
Platelet Count, Mon 12, n=161	-5.2 (40.72)
Platelet Count, Mon 16, n=94	-0.2 (46.65)
Platelet Count, Mon 20, n=91	-1.9 (44.44)
Platelet Count, Mon 24, n=104	-11.0 (42.31)
Platelet Count, Mon 28, n=82	-14.4 (46.60)
Platelet Count, Mon 32, n=82	-23.2 (45.64)
Platelet Count, Mon 36, n=87	-24.4 (39.19)
Platelet Count, Mon 40, n=76	-18.0 (40.84)
Platelet Count, Mon 48, n=77	-16.1 (41.68)
Platelet Count, Mon 52, n=65	-17.5 (35.27)
Platelet Count, Mon 56, n=62	-21.3 (36.88)
Platelet Count, Mon 60, n=68	-22.3 (38.07)
Platelet Count, Mon 64, n=47	-20.2 (47.45)
Platelet Count, Mon 68, n=44	-21.0 (48.34)
Platelet Count, Mon 72, n=52	-15.7 (43.17)
Platelet Count, Mon 76, n=31	-11.5 (52.19)
Platelet Count, Mon 80, n=24	-6.3 (43.84)
Platelet Count, Mon 84, n=35	-4.3 (40.03)
Platelet Count, Mon 88, n=16	-10.2 (30.96)
Platelet Count, Mon 92, n=15	-2.9 (25.92)
Platelet Count, Mon 96, n=19	-7.2 (37.84)
Platelet Count, Mon 100, n=7	-14.3 (50.43)
Platelet Count, Mon 104, n=1	-46.0 (NA)
Platelet Count, Mon 108, n=10	-22.3 (40.89)
WBC, Mon 1, n=169	-0.00 (1.708)
WBC, Mon 2, n=15	-0.53 (2.281)
WBC, Mon 3, n=154	0.10 (1.434)
WBC, Mon 4, n=26	0.17 (1.279)
WBC, Mon 6, n=137	0.06 (1.235)
WBC, Mon 8, n=43	-0.11 (1.577)
WBC, Mon 9, n=122	0.05 (1.356)
WBC, Mon 10, n=55	0.33 (1.654)
WBC, Mon 12, n=167	0.30 (1.500)
WBC, Mon 16, n=99	0.20 (1.362)
WBC, Mon 20, n=96	0.14 (1.274)
WBC, Mon 24, n=110	0.16 (1.398)
WBC, Mon 28, n=85	-0.14 (1.303)
WBC, Mon 32, n=86	0.02 (1.347)
WBC, Mon 36, n=91	-0.14 (1.233)
WBC, Mon 40, n=78	0.13 (1.331)
WBC, Mon 44, n=74	-0.04 (1.372)
WBC, Mon 48, n=79	0.24 (1.438)
WBC, Mon 52, n=68	0.09 (1.397)
WBC, Mon 56, n=63	-0.04 (1.198)
WBC, Mon 60, n=71	0.18 (1.892)
WBC, Mon 64, n=49	-0.09 (1.236)
WBC, Mon 68, n=44	0.27 (1.463)
WBC, Mon 72, n=53	0.27 (1.502)
WBC, Mon 76, n=31	0.51 (1.252)
WBC, Mon 80, n=24	0.65 (1.219)
WBC, Mon 84, n=35	0.93 (1.290)
WBC, Mon 88, n=16	0.25 (0.836)
WBC, Mon 92, n=15	0.73 (1.348)
WBC, Mon 96, n=19	0.79 (1.129)
WBC, Mon 100, n=7	0.36 (0.483)
WBC, Mon 104, n=1	0.30 (NA)
WBC, Mon 108, n=10	0.31 (0.743)

12. Primary Outcome

Title	Change From Baseline in Hematology Parameter-Red Blood Cell Count
Description	Red Blood Cell count (RBC) was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
RBC, Mon 1, n=169	-0.09 (0.281)
RBC, Mon 2, n=15	0.01 (0.222)
RBC, Mon 3, n=154	-0.06 (0.309)
RBC, Mon 4, n=26	-0.16 (0.305)
RBC, Mon 6, n=137	-0.04 (0.287)
RBC, Mon 8, n=43	-0.03 (0.312)
RBC, Mon 9, n=122	-0.06 (0.294)
RBC, Mon 10, n=55	-0.01 (0.299)
RBC, Mon 12, n=167	0.00 (0.291)
RBC, Mon 16, n=99	-0.04 (0.320)
RBC, Mon 20, n=96	0.01 (0.329)
RBC, Mon 24, n=110	-0.01 (0.290)
RBC, Mon 28, n=85	-0.04 (0.324)
RBC, Mon 32, n=86	-0.03 (0.322)
RBC, Mon 36, n=91	-0.11 (0.288)
RBC, Mon 40, n=78	-0.11 (0.320)
RBC, Mon 44, n=74	-0.09 (0.318)
RBC, Mon 48, n=79	-0.16 (0.316)
RBC, Mon 52, n=68	-0.08 (0.336)
RBC, Mon 56, n=63	-0.13 (0.272)
RBC, Mon 60, n=71	-0.14 (0.317)
RBC, Mon 64, n=49	-0.10 (0.323)
RBC, Mon 68, n=44	-0.06 (0.326)
RBC, Mon 72, n=53	-0.09 (0.363)
RBC, Mon 76, n=31	0.00 (0.373)
RBC, Mon 80, n=24	-0.03 (0.343)
RBC, Mon 84, n=35	-0.00 (0.379)
RBC, Mon 88, n=16	0.03 (0.353)
RBC, Mon 92, n=15	0.14 (0.300)
RBC, Mon 96, n=19	0.04 (0.248)
RBC, Mon 100, n=7	0.23 (0.287)
RBC, Mon 104, n=1	0.30 (NA)
RBC, Mon 108, n=10	0.15 (0.207)

13. Primary Outcome

Title	Change From Baseline in Haematocrit
Description	Haematocrit was assessed at Month 1, Month 2, Month 3, Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Haematocrit, Mon 1, n=165	-0.009 (0.0272)
Haematocrit, Mon 2, n=15	-0.001 (0.0210)
Haematocrit, Mon 3, n=153	-0.007 (0.0287)
Haematocrit, Mon 4, n=26	-0.012 (0.0293)
Haematocrit, Mon 6, n=136	-0.004 (0.0262)
Haematocrit, Mon 8, n=41	-0.005 (0.0248)
Haematocrit, Mon 9, n=120	-0.006 (0.0272)
Haematocrit, Mon 10, n=55	-0.002 (0.0295)
Haematocrit, Mon 12, n=162	-0.001 (0.0291)
Haematocrit, Mon 16, n=98	-0.005 (0.0292)
Haematocrit, Mon 20, n=94	-0.001 (0.0280)
Haematocrit, Mon 24, n=109	-0.002 (0.0267)
Haematocrit, Mon 28, n=84	-0.004 (0.0250)
Haematocrit, Mon 32, n=85	-0.001 (0.0273)
Haematocrit, Mon 36, n=91	-0.005 (0.0298)
Haematocrit, Mon 40, n=77	-0.004 (0.0319)
Haematocrit, Mon 44, n=73	-0.002 (0.0287)
Haematocrit, Mon 48, n=76	-0.009 (0.0376)
Haematocrit, Mon 52, n=67	0.001 (0.0347)
Haematocrit, Mon 56, n=62	-0.001 (0.0335)
Haematocrit, Mon 60, n=71	0.005 (0.0352)
Haematocrit, Mon 64, n=49	0.004 (0.0332)
Haematocrit, Mon 68, n=44	0.011 (0.0345)
Haematocrit, Mon 72, n=53	0.008 (0.0346)
Haematocrit, Mon 76, n=31	0.014 (0.0350)
Haematocrit, Mon 80, n=23	0.009 (0.0272)
Haematocrit, Mon 84, n=34	0.007 (0.0379)
Haematocrit, Mon 88, n=16	0.017 (0.0332)
Haematocrit, Mon 92, n=14	0.027 (0.0267)
Haematocrit, Mon 96, n=18	0.017 (0.0311)
Haematocrit, Mon 100, n=6	0.028 (0.0232)
Haematocrit, Mon 108, n=9	0.030 (0.0283)

14. Primary Outcome

Title	Change From Baseline in Haemoglobin
Description	Haemoglobin was assessed at Month 1, Month 2, Month 3, , Month 6, Month 8, Month 9, Month 10, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available..
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Haemoglobin, Mon 1, n=169	-3.2 (8.97)
Haemoglobin, Mon 2, n=15	-0.9 (7.26)
Haemoglobin, Mon 3, n=154	-2.6 (9.41)
Haemoglobin, Mon 4, n=26	-5.7 (10.44)
Haemoglobin, Mon 6, n=137	-2.2 (9.31)
Haemoglobin, Mon 8, n=43	-1.9 (9.40)
Haemoglobin, Mon 9, n=122	-2.9 (9.45)
Haemoglobin, Mon 10, n=55	-0.9 (9.26)
Haemoglobin, Mon 12, n=167	-0.7 (9.61)
Haemoglobin, Mon 16, n=98	-2.5 (9.96)
Haemoglobin, Mon 20, n=96	-1.4 (9.34)
Haemoglobin, Mon 24, n=110	-2.2 (8.76)
Haemoglobin, Mon 28, n=85	-3.2 (9.49)
Haemoglobin, Mon 32, n=86	-2.2 (8.84)
Haemoglobin, Mon 36, n=91	-3.3 (10.04)
Haemoglobin, Mon 40, n=78	-3.4 (10.88)
Haemoglobin, Mon 44, n=74	-2.3 (9.74)
Haemoglobin, Mon 48, n=79	-4.3 (11.13)
Haemoglobin, Mon 52, n=68	-2.0 (9.51)
Haemoglobin, Mon 56, n=63	-2.8 (9.33)
Haemoglobin, Mon 60, n=71	-2.9 (10.15)
Haemoglobin, Mon 64, n=49	-3.7 (10.55)
Haemoglobin, Mon 68, n=44	-2.0 (10.41)
Haemoglobin, Mon 72, n=53	-3.8 (11.03)
Haemoglobin, Mon 76, n=31	-3.1 (11.65)
Haemoglobin, Mon 80, n=24	-3.7 (9.24)
Haemoglobin, Mon 84, n=35	-3.8 (11.97)
Haemoglobin, Mon 88, n=16	-3.1 (9.76)
Haemoglobin, Mon 92, n=15	0.7 (9.14)
Haemoglobin, Mon 96, n=19	-2.1 (7.57)
Haemoglobin, Mon 100, n=7	2.6 (8.87)
Haemoglobin, Mon 104, n=1	8.0 (NA)
Haemoglobin, Mon 108, n=10	0.5 (7.47)

15. Primary Outcome

Title	Change From Baseline in Chemistry Parameters-Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST)
Description	Alkaline phosphatase (AP), Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
AP, Mon 1, n=151	-5.5 (19.98)
AP, Mon 3, n=136	-5.7 (19.47)
AP, Mon 6, n=122	-7.3 (19.09)
AP, Mon 9, n=108	-7.7 (23.88)
AP, Mon 12, n=149	-6.1 (21.91)
AP, Mon 16, n=87	-9.1 (22.30)
AP, Mon 20, n=85	-5.0 (23.46)
AP, Mon 24, n=95	-7.1 (22.88)
AP, Mon 28, n=75	-6.3 (23.89)
AP, Mon 32, n=73	-7.8 (23.52)
AP, Mon 36, n=77	-4.8 (20.58)
AP, Mon 40, n=67	-6.3 (23.26)
AP, Mon 44, n=63	-8.2 (21.05)
AP, Mon 48, n=70	-7.5 (23.66)
AP, Mon 52, n=59	-9.7 (22.18)
AP, Mon 56, n=54	-9.9 (23.41)
AP, Mon 60, n=61	-7.7 (21.83)
AP, Mon 64, n=44	-2.8 (29.20)
AP, Mon 68, n=36	-8.7 (24.79)
AP, Mon 72, n=46	-4.5 (24.32)
AP, Mon 76, n=26	-5.0 (23.34)
AP, Mon 80, n=21	-8.9 (28.32)
AP, Mon 84, n=30	-1.7 (24.36)
AP, Mon 88, n=15	-9.9 (19.57)
AP, Mon 92, n=15	-6.5 (24.01)
AP, Mon 96, n=18	-3.9 (17.32)
AP, Mon 100, n=6	-12.3 (26.47)
AP, Mon 104, n=1	11.0 (NA)
AP, Mon 108, n=9	-14.2 (21.81)
ALT, Mon 1, n=169	3.1 (16.74)
ALT, Mon 3, n=152	4.0 (16.61)
ALT, Mon 6, n=137	1.2 (10.45)
ALT, Mon 9, n=122	5.2 (43.44)
ALT, Mon 12, n=169	4.5 (26.42)
ALT, Mon 16, n=100	-0.3 (11.05)
ALT, Mon 20, n=96	1.1 (10.89)
ALT, Mon 24, n=108	3.0 (11.61)
ALT, Mon 28, n=87	2.2 (12.65)
ALT, Mon 32, n=85	2.0 (14.39)
ALT, Mon 36, n=89	1.7 (10.36)
ALT, Mon 40, n=77	2.5 (12.6)
ALT, Mon 44, n=73	4.1 (13.29)
ALT, Mon 48, n=78	3.0 (12.25)
ALT, Mon 52, n=67	2.3 (12.15)
ALT, Mon 56, n=62	1.4 (9.94)
ALT, Mon 60, n=69	1.0 (11.73)
ALT, Mon 64, n=48	0.2 (10.24)
ALT, Mon 68, n=41	-0.5 (9.11)
ALT, Mon 72, n=51	0.4 (10.15)
ALT, Mon 76, n=30	0.6 (6.14)
ALT, Mon 80, n=22	0.4 (12.38)
ALT, Mon 84, n=33	1.1 (12.05)
ALT, Mon 88, n=15	-1.3 (12.29)
ALT, Mon 92, n=15	2.1 (8.09)
ALT, Mon 96, n=18	2.2 (13.81)
ALT, Mon 100, n=6	0.8 (9.41)
ALT, Mon 104, n=1	-6.0 (NA)
ALT, Mon 108, n=9	-1.3 (6.86)
AST, Mon 1, n=169	2.9 (10.79)
AST, Mon 3, n=152	3.2 (10.07)
AST, Mon 6, n=137	1.7 (7.89)
AST, Mon 9, n=121	6.0 (35.18)
AST, Mon 12, n=169	3.9 (14.84)
AST, Mon 16, n=100	2.1 (8.49)
AST, Mon 20, n=96	2.9 (8.03)
AST, Mon 24, n=108	4.1 (9.72)
AST, Mon 28, n=86	4.3 (9.16)
AST, Mon 32, n=85	5.6 (8.64)
AST, Mon 36, n=89	3.9 (6.74)
AST, Mon 40, n=77	5.0 (9.93)
AST, Mon 44, n=73	4.6 (7.84)
AST, Mon 48, n=78	4.7 (8.61)
AST, Mon 52, n=67	6.0 (8.68)
AST, Mon 56, n=62	4.3 (7.61)
AST, Mon 60, n=69	5.4 (9.34)
AST, Mon 64, n=48	3.8 (8.50)
AST, Mon 68, n=41	5.3 (7.13)
AST, Mon 72, n=51	5.1 (9.54)
AST, Mon 76, n=30	4.9 (6.59)
AST, Mon 80, n=22	4.6 (7.74)
AST, Mon 84, n=33	5.6 (8.60)
AST, Mon 88, n=15	2.9 (6.99)
AST, Mon 92, n=15	3.3 (3.24)
AST, Mon 96, n=18	3.1 (6.58)
AST, Mon 100, n=6	3.7 (4.23)
AST, Mon 104, n=1	2.0 (NA)
AST, Mon 108, n=9	1.8 (5.49)

16. Primary Outcome

Title	Change From Baseline in Chemistry Parameters-Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium, Urea
Description	Bicarbonate (Bic.), BUN, Calcium (Ca), Chloride (Cl), Cholesterol (Cho.), Non-fasting glucose (NFG), Phosphorus (P), Potassium (Ka), Sodium (Na), Urea were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
BUN, Mon 3, n=142	0.843 (1.2012)
BUN, Mon 6, n=130	0.917 (1.3506)
BUN, Mon 9, n=115	0.823 (1.4786)
BUN, Mon 12, n=156	0.717 (1.3707)
BUN, Mon 16, n=94	0.973 (1.5385)
BUN, Mon 20, n=92	1.060 (1.3001)
BUN, Mon 24, n=102	0.809 (1.3654)
BUN, Mon 28, n=82	0.876 (1.6420)
BUN, Mon 32, n=80	0.942 (1.5201)
BUN, Mon 36, n=85	0.958 (1.4267)
BUN, Mon 40, n=72	1.135 (1.5626)
BUN, Mon 44, n=69	0.844 (1.5006)
BUN, Mon 48, n=75	0.952 (1.5679)
BUN, Mon 52, n=62	1.071 (1.4554)
BUN, Mon 56, n=57	1.022 (1.2697)
BUN, Mon 60, n=64	1.100 (1.4931)
BUN, Mon 64, n=44	0.991 (1.5938)
BUN, Mon 68, n=37	1.148 (1.4599)
BUN, Mon 72, n=48	1.087 (1.6218)
BUN, Mon 76, n=27	1.257 (1.4492)
BUN, Mon 80, n=19	0.939 (1.6115)
BUN, Mon 84, n=30	0.929 (1.6810)
BUN, Mon 88, n=15	0.881 (1.458)
BUN, Mon 92, n=15	1.332 (1.9374)
BUN, Mon 96, n=18	0.916 (1.8800)
BUN, Mon 100, n=6	1.248 (1.5755)
BUN, Mon 104, n=1	1.430 (NA)
BUN, Mon 108, n=9	0.183 (1.2637)
Ca, Mon 1, n=170	-0.034 (0.1094)
Ca, Mon 3, n=152	-0.013 (0.1107)
Ca, Mon 6, n=137	0.012 (0.1035)
Ca, Mon 9, n=123	0.020 (0.1006)
Ca, Mon 12, n=169	0.024 (0.1167)
Ca, Mon 16, n=100	0.042 (0.1143)
Ca, Mon 20, n=97	0.052 (0.1180)
Ca, Mon 24, n=109	0.049 (0.1095)
Ca, Mon 28, n=87	0.034 (0.1135)
Ca, Mon 32, n=85	0.032 (0.1216)
Ca, Mon 36, n=89	0.032 (0.1176)
Ca, Mon 40, n=77	0.030 (0.1195)
Ca, Mon 44, n=73	0.040 (0.1093)
Ca, Mon 48, n=80	0.054 (0.1161)
Ca, Mon 52, n=67	0.047 (0.1170)
Ca, Mon 56, n=62	0.055 (0.0951)
Ca, Mon 60, n=69	0.061 (0.1184)
Ca, Mon 64, n=49	0.056 (0.1338)
Ca, Mon 68, n=41	0.083 (0.1245)
Ca, Mon 72, n=51	0.053 (0.1223)
Ca, Mon 76, n=30	0.097 (0.1341)
Ca, Mon 80, n=22	0.069 (0.1289)
Ca, Mon 84, n=34	0.106 (0.1023)
Ca, Mon 88, n=15	0.071 (0.1078)
Ca, Mon 92, n=15	0.116 (0.1013)
Ca, Mon 96, n=18	0.106 (0.0887)
Ca, Mon 100, n=6	0.148 (0.1217)
Ca, Mon 104, n=1	0.170 (NA)
Ca, Mon 108, n=9	0.139 (0.1122)
Cho., Mon 3, n=151	0.075 (0.6672)
Cho., Mon 6, n=137	0.069 (0.6811)
Cho., Mon 9, n=122	0.177 (0.7230)
Cho., Mon 12, n=169	0.222 (0.7098)
Cho., Mon 16, n=100	0.310 (0.7312)
Cho., Mon 20, n=97	0.304 (0.7883)
Cho., Mon 24, n=109	0.260 (0.7731)
Cho., Mon 28, n=87	0.261 (0.7771)
Cho., Mon 32, n=85	0.261 (0.8061)
Cho., Mon 36, n=89	0.212 (0.8312)
Cho., Mon 40, n=77	0.200 (0.7782)
Cho., Mon 44, n=73	0.348 (0.7824)
Cho., Mon 48, n=79	0.170 (0.8571)
Cho., Mon 52, n=67	0.299 (0.7230)
Cho., Mon 56, n=62	0.305 (0.7202)
Cho., Mon 60, n=69	0.360 (0.7318)
Cho., Mon 64, n=49	0.256 (0.8771)
Cho., Mon 68, n=41	0.352 (0.8486)
Cho., Mon 72, n=51	0.216 (0.8548)
Cho., Mon 76, n=30	0.555 (0.7532)
Cho., Mon 80, n=22	0.442 (0.7078)
Cho., Mon 84, n=34	0.459 (0.9991)
Cho., Mon 88, n=15	0.408 (0.7559)
Cho., Mon 92, n=15	0.526 (0.7639)
Cho., Mon 96, n=18	0.352 (0.628)
Cho., Mon 100, n=6	0.483 (0.4126)
Cho., Mon 104, n=1	0.160 (NA)
Cho., Mon 108, n=9	0.278 (0.3881)
NFG, Mon 1, n=170	0.11 (0.929)
NFG, Mon 3, n=149	0.20 (0.844)
NFG, Mon 6, n=133	0.18 (1.057)
NFG, Mon 9, n=120	0.38 (2.585)
NFG, Mon 12, n=166	0.20 (0.978)
NFG, Mon 16, n=100	0.18 (1.167)
NFG, Mon 20, n=94	0.26 (0.971)
NFG, Mon 24, n=106	0.13 (0.935)
NFG, Mon 28, n=86	0.22 (0.968)
NFG, Mon 32, n=85	0.16 (1.39)
NFG, Mon 36, n=89	0.19 (1.176)
NFG, Mon 40, n=75	0.20 (1.074)
NFG, Mon 44, n=72	0.02 (1.019)
NFG, Mon 48, n=77	0.27 (1.628)
NFG, Mon 52, n=67	0.05 (0.877)
NFG, Mon 56, n=61	0.14 (0.893)
NFG, Mon 60, n=69	0.19 (1.029)
NFG, Mon 64, n=49	0.21 (0.883)
NFG, Mon 68, n=39	0.32 (0.700)
NFG, Mon 72, n=51	0.24 (1.037)
NFG, Mon 76, n=30	0.17 (0.505)
NFG, Mon 80, n=22	0.15 (0.776)
NFG, Mon 84, n=34	0.23 (0.572)
NFG, Mon 88, n=15	-0.09 (0.593)
NFG, Mon 92, n=15	0.14 (0.546)
NFG, Mon 96, n=18	0.22 (0.493)
NFG, Mon 100, n=6	0.25 (0.176)
NFG, Mon 104, n=1	-0.50 (NA)
NFG, Mon 108, n=9	0.21 (0.372)
P, Mon 1, n=169	0.014 (0.2037)
P, Mon 3, n=148	0.001 (0.2029)
P, Mon 6, n=132	0.020 (0.2148)
P, Mon 9, n=119	0.021 (0.1974)
P, Mon 12, n=167	0.007 (0.2401)
P, Mon 16, n=100	-0.010 (0.2289)
P, Mon 20, n=94	0.003 (0.2229)
P, Mon 24, n=105	-0.021 (0.2186)
P, Mon 28, n=86	-0.020 (0.1974)
P, Mon 32, n=84	0.019 (0.1767)
P, Mon 36, n=88	0.004 (0.2896)
P, Mon 40, n=75	-0.005 (0.2408)
P, Mon 44, n=73	0.018 (0.2631)
P, Mon 48, n=78	0.019 (0.2165)
P, Mon 52, n=67	0.018 (0.2160)
P, Mon 56, n=62	0.010 (0.2330)
P, Mon 60, n=69	0.071 (0.2389)
P, Mon 64, n=49	0.027 (0.2722)
P, Mon 68, n=39	0.007 (0.2453)
P, Mon 72, n=51	0.029 (0.2761)
P, Mon 76, n=30	0.038 (0.2506)
P, Mon 80, n=22	0.107 (0.2761)
P, Mon 84, n=34	0.046 (0.2518)
P, Mon 88, n=15	-0.004 (0.2970)
P, Mon 92, n=15	0.058 (0.3334)
P, Mon 96, n=18	0.026 (0.3294)
P, Mon 100, n=6	0.143 (0.1656)
P, Mon 104, n=1	-0.090 (NA)
P, Mon 108, n=9	-0.068 (0.3755)
Ka, Mon 1, n=169	0.02 (0.416)
Ka, Mon 3, n=149	0.04 (0.433)
Ka, Mon 6, n=132	0.03 (0.362)
Ka, Mon 9, n=119	0.08 (0.432)
Ka, Mon 12, n=167	-0.03 (0.442)
Ka, Mon 16, n=100	0.02 (0.428)
Ka, Mon 20, n=93	0.10 (0.442)
Ka, Mon 24, n=106	-0.00 (0.435)
Ka, Mon 28, n=86	-0.01 (0.437)
Ka, Mon 32, n=84	0.01 (0.408)
Ka, Mon 36, n=88	0.04 (0.482)
Ka, Mon 40, n=74	0.00 (0.432)
Ka, Mon 44, n=74	0.16 (0.538)
Ka, Mon 48, n=79	0.12 (0.400)
Ka, Mon 52, n=67	0.20 (0.448)
Ka, Mon 56, n=62	0.08 (0.374)
Ka, Mon 60, n=69	0.13 (0.511)
Ka, Mon 64, n=49	0.19 (0.407)
Ka, Mon 68, n=40	0.28 (0.394)
Ka, Mon 72, n=52	0.24 (0.546)
Ka, Mon 76, n=30	0.25 (0.549)
Ka, Mon 80, n=22	0.35 (0.448)
Ka, Mon 84, n=34	0.24 (0.483)
Ka, Mon 88, n=15	0.38 (0.430)
Ka, Mon 92, n=15	0.55 (0.503)
Ka, Mon 96, n=18	0.41 (0.407)
Ka, Mon 100, n=6	0.32 (0.402)
Ka, Mon 104, n=1	1.10 (NA)
Ka, Mon 108, n=9	0.51 (0.437)
Na, Mon 1, n=170	1.5 (3.44)
Na, Mon 3, n=153	1.4 (2.88)
Na, Mon 6, n=137	1.8 (3.16)
Na, Mon 9, n=123	1.5 (3.22)
Na, Mon 12, n=170	1.1 (3.68)
Na, Mon 16, n=100	1.3 (3.26)
Na, Mon 20, n=97	1.1 (3.33)
Na, Mon 24, n=110	0.8 (3.57)
Na, Mon 28, n=87	1.4 (3.06)
Na, Mon 32, n=85	1.2 (3.46)
Na, Mon 36, n=89	1.3 (3.84)
Na, Mon 40, n=77	1.6 (3.78)
Na, Mon 44, n=74	1.4 (3.78)
Na, Mon 48, n=80	1.2 (3.31)
Na, Mon 52, n=67	1.5 (4.09)
Na, Mon 56, n=62	2.2 (3.21)
Na, Mon 60, n=69	1.6 (3.46)
Na, Mon 64, n=49	2.3 (3.63)
Na, Mon 68, n=42	2.8 (3.64)
Na, Mon 72, n=52	2.5 (3.60)
Na, Mon 76, n=30	3.7 (3.43)
Na, Mon 80, n=22	3.5 (4.15)
Na, Mon 84, n=34	2.9 (4.04)
Na, Mon 88, n=15	3.4 (3.18)
Na, Mon 92, n=15	2.8 (2.46)
Na, Mon 96, n=18	2.9 (2.24)
Na, Mon 100, n=6	3.5 (4.09)
Na, Mon 104, n=1	8.0 (NA)
Na, Mon 108, n=9	3.8 (4.35)
Urea, Mon 1, n=13	0.712 (1.1012)
Urea, Mon 3, n=10	0.533 (0.5127)
Urea, Mon 6, n=7	0.304 (1.1204)
Urea, Mon 9, n=8	0.846 (1.1121)
Urea, Mon 12, n=13	0.713 (0.8743)
Urea, Mon 16, n=6	1.070 (2.1793)
Urea, Mon 20, n=5	0.856 (0.7814)
Urea, Mon 24, n=8	0.668 (1.0143)
Urea, Mon 28, n=5	1.498 (0.9608)
Urea, Mon 32, n=5	0.784 (0.7722)
Urea, Mon 36, n=4	1.337 (1.5564)
Urea, Mon 40, n=5	1.140 (0.4659)
Urea, Mon 44, n=5	0.784 (0.5269)
Urea, Mon 48, n=5	0.712 (1.1305)
Urea, Mon 52, n=5	0.356 (0.9411)
Urea, Mon 56, n=5	1.356 (1.7009)
Urea, Mon 60, n=5	1.282 (1.7228)
Urea, Mon 64, n=5	1.496 (0.8128)
Urea, Mon 68, n=4	1.695 (1.0242)
Urea, Mon 72, n=3	1.070 (2.1725)
Urea, Mon 76, n=3	1.070 (0.9430)
Urea, Mon 80, n=3	2.380 (0.7398)
Urea, Mon 84, n=4	1.695 (1.9006)
Bicarbonate, Mon 1, n=169	0.4 (3.13)
Bicarbonate, Mon 3, n=151	0.0 (3.27)
Bicarbonate, Mon 6, n=136	0.4 (3.65)
Bicarbonate, Mon 9, n=122	0.7 (3.48)
Bicarbonate, Mon 12, n=169	-0.0 (3.97)
Bicarbonate, Mon 16, n=100	1.2 (3.49)
Bicarbonate, Mon 20, n=97	1.5 (4.02)
Bicarbonate, Mon 24, n=109	1.1 (3.28)
Bicarbonate, Mon 28, n=87	1.6 (3.67)
Bicarbonate, Mon 32, n=85	1.7 (3.62)
Bicarbonate, Mon 36, n=89	1.6 (3.84)
Bicarbonate, Mon 40, n=76	1.9 (3.89)
Bicarbonate, Mon 44, n=73	2.7 (3.99)
Bicarbonate, Mon 48, n=79	2.4 (3.43)
Bicarbonate, Mon 52, n=66	2.8 (3.65)
Bicarbonate, Mon 56, n=62	1.8 (3.79)
Bicarbonate, Mon 60, n=69	2.4 (4.33)
Bicarbonate, Mon 64, n=49	1.9 (3.95)
Bicarbonate, Mon 68, n=42	2.0 (3.84)
Bicarbonate, Mon 72, n=51	1.8 (3.59)
Bicarbonate, Mon 76, n=30	2.2 (4.04)
Bicarbonate, Mon 80, n=22	2.2 (3.74)
Bicarbonate, Mon 84, n=34	3.0 (5.49)
Bicarbonate, Mon 88, n=15	1.7 (2.09)
Bicarbonate, Mon 92, n=15	1.7 (2.55)
Bicarbonate, Mon 96, n=18	1.2 (3.73)
Bicarbonate, Mon 100, n=6	-0.7 (1.86)
Bicarbonate, Mon 104, n=1	1.0 (NA)
Bicarbonate, Mon 108, n=9	-0.4 (2.30)
Cl, Mon 1, n=170	1.3 (3.38)
Cl, Mon 3, n=153	1.3 (3.06)
Cl, Mon 6, n=137	1.4 (3.32)
Cl, Mon 9, n=123	1.6 (3.59)
Cl, Mon 12, n=169	1.0 (3.73)
Cl, Mon 16, n=100	1.8 (3.24)
Cl, Mon 20, n=97	1.2 (3.56)
Cl, Mon 24, n=110	1.0 (4.12)
Cl, Mon 28, n=87	1.6 (3.45)
Cl, Mon 32, n=85	1.8 (3.70)
Cl, Mon 36, n=89	1.5 (4.00)
Cl, Mon 40, n=77	1.6 (4.12)
Cl, Mon 44, n=74	1.3 (3.81)
Cl, Mon 48, n=80	1.2 (3.61)
Cl, Mon 52, n=67	1.4 (4.13)
Cl, Mon 56, n=61	2.0 (3.29)
Cl, Mon 60, n=69	1.0 (3.77)
Cl, Mon 64, n=49	1.7 (3.44)
Cl, Mon 68, n=42	1.2 (3.62)
Cl, Mon 72, n=52	1.6 (3.70)
Cl, Mon 76, n=30	1.6 (4.11)
Cl, Mon 80, n=22	2.0 (3.54)
Cl, Mon 84, n=34	0.9 (3.53)
Cl, Mon 88, n=15	2.2 (2.31)
Cl, Mon 92, n=15	0.9 (3.11)
Cl, Mon 96, n=18	0.7 (3.66)
Cl, Mon 100, n=6	1.8 (4.26)
Cl, Mon 104, n=1	1.0 (NA)
Cl, Mon 108, n=9	0.8 (3.56)

17. Primary Outcome

Title	Change From Baseline in Chemistry Parameters -Creatinine, Total Bilirubin (TB), Uric Acid (UA)
Description	Creatinine, Total bilirubin (TB), Uric acid (UA) were assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Creatinine, Mon 1, n=170	3 (12.20)
Creatinine, Mon 3, n=149	4 (13.74)
Creatinine, Mon 6, n=133	4.9 (13.47)
Creatinine, Mon 9, n=120	3.7 (14.88)
Creatinine, Mon 12, n=167	4.5 (13.91)
Creatinine, Mon 16, n=100	4.0 (15.25)
Creatinine, Mon 20, n=94	3.0 (15.67)
Creatinine, Mon 24, n=105	1.9 (17.15)
Creatinine, Mon 28, n=86	-1.0 (13.98)
Creatinine, Mon 32, n=84	0.0 (16.60)
Creatinine, Mon 36, n=88	-0.9 (14.90)
Creatinine, Mon 40, n=75	0.1 (14.38)
Creatinine, Mon 44, n=73	-1.0 (13.93)
Creatinine, Mon 48, n=79	-0.2 (15.16)
Creatinine, Mon 52, n=67	0.1 (14.84)
Creatinine, Mon 56, n=62	1.2 (11.42)
Creatinine, Mon 60, n=69	-0.2 (15.54)
Creatinine, Mon 64, n=49	0.6 (15.19)
Creatinine, Mon 68, n=39	0.7 (14.31)
Creatinine, Mon 72, n=51	0.1 (14.35)
Creatinine, Mon 76, n=30	0.5 (14.75)
Creatinine, Mon 80, n=22	3.3 (13.38)
Creatinine, Mon 84, n=34	1.6 (18.72)
Creatinine, Mon 88, n=15	1.2 (12.37)
Creatinine, Mon 92, n=15	4.3 (12.45)
Creatinine, Mon 96, n=18	1.2 (10.86)
Creatinine, Mon 100, n=6	6.2 (12.06)
Creatinine, Mon 104, n=1	9.0 (NA)
Creatinine, Mon 108, n=9	5.3 (14.40)
TB Mon 1, n=167	4.6 (4.06)
TB Mon 3, n=150	4.5 (4.34)
TB Mon 6, n=134	3.8 (4.04)
TB Mon 9, n=120	3.6 (4.40)
TB Mon 12, n=167	2.7 (4.10)
TB Mon 16, n=100	3.6 (4.41)
TB Mon 20, n=97	3.7 (3.89)
TB Mon 24, n=109	2.6 (4.10)
TB Mon 28, n=87	2.8 (4.26)
TB Mon 32, n=85	2.4 (4.95)
TB Mon 36, n=89	2.2 (4.26)
TB Mon 40, n=77	2.7 (4.68)
TB Mon 44, n=73	2.6 (4.33)
TB Mon 48, n=78	2.2 (4.98)
TB Mon 52, n=67	2.0 (4.75)
TB Mon 56, n=62	2.1 (4.54)
TB Mon 60, n=68	2.1 (4.75)
TB Mon 64, n=48	1.6 (4.56)
TB Mon 68, n=41	1.2 (4.97)
TB Mon 72, n=51	0.8 (4.64)
TB Mon 76, n=29	1.0 (4.38)
TB Mon 80, n=22	1.3 (3.69)
TB Mon 84, n=34	-0.3 (4.09)
TB Mon 88, n=15	2.1 (7.05)
TB Mon 92, n=15	1.3 (4.89)
TB Mon 96, n=18	-0.2 (5.06)
TB Mon 100, n=6	1.2 (4.49)
TB Mon 104, n=1	9.0 (NA)
TB Mon 108, n=9	-0.3 (2.24)
UA Mon 1, n=170	0.8 (39.49)
UA Mon 3, n=152	3.1 (47.06)
UA Mon 6, n=137	2.9 (44.98)
UA Mon 9, n=123	4.5 (48.74)
UA Mon 12, n=169	6.6 (50.88)
UA Mon 16, n=100	2.5 (55.01)
UA Mon 20, n=97	2.3 (49.72)
UA Mon 24, n=109	4.7 (53.68)
UA Mon 28, n=87	12.2 (51.73)
UA Mon 32, n=85	10.2 (48.23)
UA Mon 36, n=89	5.3 (52.19)
UA Mon 40, n=77	6.9 (45.40)
UA Mon 44, n=73	4.3 (53.75)
UA Mon 48, n=79	5.7 (45.68)
UA Mon 52, n=67	4.2 (52.86)
UA Mon 56, n=62	8.6 (42.81)
UA Mon 60, n=69	8.1 (49.74)
UA Mon 64, n=49	2.7 (52.52)
UA Mon 68, n=41	5.4 (52.49)
UA Mon 72, n=51	12.6 (56.31)
UA Mon 76, n=30	11.9 (53.61)
UA Mon 80, n=22	7.0 (50.68)
UA Mon 84, n=34	5.7 (58.19)
UA Mon 88, n=15	3.1 (57.81)
UA Mon 92, n=15	-6.0 (60.45)
UA Mon 96, n=18	5.3 (52.95)
UA Mon 100, n=6	35.7 (62.78)
UA Mon 104, n=1	107.0 (NA)
UA Mon 108, n=9	17.9 (59.95)

18. Primary Outcome

Title	Change From Baseline in Chemistry Parameter-Total Protein
Description	Total Protein (TP) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
TP Mon 1, n=170	-1.1 (4.44)
TP Mon 3, n=152	-0.5 (4.87)
TP Mon 6, n=137	-1.0 (4.77)
TP Mon 9, n=123	-0.8 (4.60)
TP Mon 12, n=169	0.2 (4.45)
TP Mon 16, n=100	0.3 (5.15)
TP Mon 20, n=97	0.8 (4.64)
TP Mon 24, n=109	0.2 (4.67)
TP Mon 28, n=87	-0.2 (4.52)
TP Mon 32, n=85	0.1 (4.55)
TP Mon 36, n=89	-1.1 (4.48)
TP Mon 40, n=77	-1.1 (4.46)
TP Mon 44, n=73	-0.1 (4.72)
TP Mon 48, n=79	-1.3 (4.34)
TP Mon 52, n=67	-0.7 (4.67)
TP Mon 56, n=62	-1.1 (4.32)
TP Mon 60, n=69	-0.7 (4.75)
TP Mon 64, n=49	-0.2 (4.86)
TP Mon 68, n=41	0.6 (4.82)
TP Mon 72, n=51	-0.7 (5.17)
TP Mon 76, n=30	0.8 (4.93)
TP Mon 80, n=22	0.3 (4.82)
TP Mon 84, n=34	0.7 (5.90)
TP Mon 88, n=15	0.4 (5.29)
TP Mon 92, n=15	1.0 (4.09)
TP Mon 96, n=18	0.9 (3.20)
TP Mon 100, n=6	2.0 (4.77)
TP Mon 104, n=1	7.0 (NA)
TP Mon 108, n=9	2.1 (4.94)

19. Primary Outcome

Title	Change From Baseline in Urine Specific Gravity
Description	Urine Specific gravity (USG) was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
USG, Mon 1, n=166	-0.0018 (0.00848)
USG, Mon 3, n=157	-0.0016 (0.00852)
USG, Mon 6, n=137	0.0002 (0.00930)
USG, Mon 9, n=121	0.0002 (0.00933)
USG, Mon 12, n=170	-0.0000 (0.00937)
USG, Mon 16, n=100	0.0006 (0.00960)
USG, Mon 20, n=97	0.0008 (0.00964)
USG, Mon 24, n=109	-0.0012 (0.00985)
USG, Mon 28, n=86	-0.0003 (0.01032)
USG, Mon 32, n=82	-0.0006 (0.00935)
USG, Mon 36, n=89	-0.0024 (0.0086)
USG, Mon 40, n=76	-0.0005 (0.00865)
USG, Mon 44, n=72	-0.0007 (0.00867)
USG, Mon 48, n=80	-0.0015 (0.00941)
USG, Mon 52, n=67	0.0002 (0.00972)
USG, Mon 56, n=62	-0.0003 (0.00899)
USG, Mon 60, n=68	-0.0023 (0.00893)
USG, Mon 64, n=49	-0.0022 (0.00938)
USG, Mon 68, n=42	-0.0022 (0.00822)
USG, Mon 72, n=53	-0.0015 (0.01006)
USG, Mon 76, n=31	-0.0024 (0.00822)
USG, Mon 80, n=23	-0.0021 (0.00867)
USG, Mon 84, n=35	-0.0028 (0.00862)
USG, Mon 88, n=17	-0.0055 (0.00833)
USG, Mon 92, n=16	-0.0030 (0.01116)
USG, Mon 96, n=19	-0.0039 (0.00956)
USG, Mon 100, n=7	-0.0013 (0.00886)
USG, Mon 104, n=1	-0.0150 (NA)
USG, Mon 108, n=10	-0.0014 (0.01032)

20. Primary Outcome

Title	Change From Baseline in Urine Power of Hydrogen (pH)
Description	Urine pH was assessed at Month 1, Month 3, , Month 6, Month 9, Month 12 and every 4 months after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). NA indicates that data were not available.
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
UpH, Mon 1, n=166	-0.13 (0.721)
UpH, Mon 3, n=157	-0.18 (0.791)
UpH, Mon 6, n=137	-0.13 (0.767)
UpH, Mon 9, n=121	-0.17 (0.771)
UpH, Mon 12, n=170	-0.11 (0.793)
UpH, Mon 16, n=100	-0.05 (0.764)
UpH, Mon 20, n=97	-0.20 (0.886)
UpH, Mon 24, n=109	-0.09 (0.713)
UpH, Mon 28, n=86	-0.01 (0.893)
UpH, Mon 32, n=82	-0.10 (0.768)
UpH, Mon 36, n=89	0.12 (0.83)
UpH, Mon 40, n=76	0.09 (0.842)
UpH, Mon 44, n=72	0.12 (0.767)
UpH, Mon 48, n=80	0.19 (0.828)
UpH, Mon 52, n=67	0.17 (0.851)
UpH, Mon 56, n=62	0.06 (0.769)
UpH, Mon 60, n=68	0.24 (0.896)
UpH, Mon 64, n=49	0.19 (0.934)
UpH, Mon 68, n=42	0.12 (0.825)
UpH, Mon 72, n=53	0.16 (0.842)
UpH, Mon 76, n=31	0.13 (1.000)
UpH, Mon 80, n=23	0.24 (0.890)
UpH, Mon 84, n=36	0.00 (0.862)
UpH, Mon 88, n=17	0.21 (1.032)
UpH, Mon 92, n=16	0.28 (1.224)
UpH, Mon 96, n=19	0.26 (0.888)
UpH, Mon 100, n=7	0.14 (1.180)
UpH, Mon 104, n=1	0.50 (NA)
UpH, Mon 108, n=10	0.65 (0.747)

21. Primary Outcome

Title	Change From Baseline in Post-void Residual Bladder Ultrasound Volume
Description	Post-void residual (PVR) bladder was assessed using ultrasound scan to assess urinary retention at Month 1, Month 3, Month 12 and annually after Month 12. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
PVR, Mon 1, n=152	6.5 (60.92)
PVR, Mon 3, n=146	5.8 (59.69)
PVR, Mon 12, n=144	-2.8 (73.95)
PVR, Mon 24, n=75	11.6 (62.06)
PVR, Mon 36, n=84	13.6 (58.45)
PVR, Mon 48, n=77	8.8 (62.28)
PVR, Mon 60, n=65	20.1 (85.81)
PVR, Mon 72, n=48	17.2 (61.82)
PVR, Mon 84, n=31	40.0 (89.38)
PVR, Mon 96, n=19	8.7 (23.32)
PVR, Mon 108, n=10	17.4 (60.89)

22. Primary Outcome

Title	Change From Baseline in Overall American Urological Association (AUA) Symptom Index Score
Description	An AUA Symptom Index is a 7-item Likert-scored scale describing urinary bladder function and was completed by the Investigator to assess the participant's urinary voiding function at Month 1, Month 3, Month 12 and annually after Month 12. The index scale ranges from 0-35, where higher scores are indicative of a worse issue. Scores are categorized as 0-7 mild, 8-19 moderate and >19 severe. Baseline assessment in this study is defined as the last assessment for the endpoint in parent study taken prior to the first active treatment with Retigabine. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame	Baseline and Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
AUA, Mon 1, n=162	-0.2 (6.17)
AUA, Mon 3, n=151	-0.0 (5.66)
AUA, Mon 12, n=153	0.2 (6.30)
AUA, Mon 24, n=79	-0.1 (5.91)
AUA, Mon 36, n=81	0.0 (4.62)
AUA, Mon 48, n=79	0.5 (5.53)
AUA, Mon 60, n=65	0.6 (4.42)
AUA, Mon 72, n=49	0.4 (4.84)
AUA, Mon 84, n=33	1.0 (4.89)
AUA, Mon 96, n=19	-1.0 (3.76)
AUA, Mon 108, n=10	-0.3 (5.06)

23. Primary Outcome

Title	Number of Participants With Abnormal Results in Physical Examination
Description	A complete physical examination was performed at the end of each 12 month study cycle. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If a participant had an abnormal result for at least one body system of exam, that participant was included in the 'Abnormal' category
Time Frame	Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study Arm
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Baseline, n=181	59 57.8%
Mon 12, n=169	49 48%
Mon 24, n=113	34 33.3%
Mon 36, n=92	27 26.5%
Mon 48, n=82	25 24.5%
Mon 60, 69	32 31.4%
Mon 72, n=56	31 30.4%
Mon 84, n=36	25 24.5%
Mon 96, n=19	10 9.8%
Mon 108, n=10	5 4.9%

24. Primary Outcome

Title	Number of Participants With Abnormal Results of Neurological Examination
Description	Participants were assessed at Month 1, Month 3, Month 6, Month 9, Month 12 and every 4 months after Month 12. Participants in the worst category among the results of all neurological examination parameters are presented. Abnormal results were categorised as Abnormal not Clinically Significant (AbNCS)and Abnormal and Clinically Significant (AbCS). Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame	Up to Month 108

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Baseline, n= 173, AbNCS	60 58.8%
Baseline, n= 173, AbCS	11 10.8%
Mon 1, n= 173, AbNCS	49 48%
Mon 1, n= 173, AbCS	17 16.7%
Mon 3, n= 159, AbNCS	42 41.2%
Mon 3, n= 159, AbCS	9 8.8%
Mon 6, n= 141, AbNCS	35 34.3%
Mon 6, n= 141, AbCS	8 7.8%
Mon 9, n= 125, AbNCS	32 31.4%
Mon 9, n= 125, AbCS	9 8.8%
Mon 12, n= 171, AbNCS	56 54.9%
Mon 12, n= 171, AbCS	13 12.7%
Mon 16, n= 104, AbNCS	23 22.5%
Mon 16, n= 104, AbCS	10 9.8%
Mon 20, n= 98, AbNCS	28 27.5%
Mon 20, n= 98, AbCS	6 5.9%
Mon 24, n= 113, AbNCS	35 34.3%
Mon 24, n= 113, AbCS	6 5.9%
Mon 28, n= 87, AbNCS	23 22.5%
Mon 28, n= 87, AbCS	6 5.9%
Mon 32, n= 86, AbNCS	19 18.6%
Mon 32, n= 86, AbCS	5 4.9%
Mon 36, n= 92, AbNCS	28 27.5%
Mon 36, n= 92, AbCS	6 5.9%
Mon 40, n= 78, AbNCS	22 21.6%
Mon 40, n= 78, AbCS	8 7.8%
Mon 44, n= 76, AbNCS	25 24.5%
Mon 44, n= 76, AbCS	3 2.9%
Mon 48, n= 82, AbNCS	25 24.5%
Mon 48, n= 82, AbCS	6 5.9%
Mon 52, n= 67, AbNCS	19 18.6%
Mon 52, n= 67, AbCS	4 3.9%
Mon 56, n= 63, AbNCS	19 18.6%
Mon 56, n= 63, AbCS	4 3.9%
Mon 60, n= 68, AbNCS	27 26.5%
Mon 60, n= 68, AbCS	3 2.9%
Mon 64, n= 50, AbNCS	21 20.6%
Mon 64, n= 50, AbCS	1 1%
Mon 68, n= 44, AbNCS	15 14.7%
Mon 68, n= 44, AbCS	0 0%
Mon 72, n= 56, AbNCS	20 19.6%
Mon 72, n= 56, AbCS	4 3.9%
Mon 76, n= 31, AbNCS	11 10.8%
Mon 76, n= 31, AbCS	0 0%
Mon 80, n= 24, AbNCS	7 6.9%
Mon 80, n= 24, AbCS	0 0%
Mon 84, n= 36, AbNCS	14 13.7%
Mon 84, n= 36, AbCS	0 0%
Mon 88, n= 17, AbNCS	0 0%
Mon 88, n= 17, AbCS	1 1%
Mon 92, n= 16, AbNCS	2 2%
Mon 92, n= 16, AbCS	1 1%
Mon 96, n= 19, AbNCS	4 3.9%
Mon 96, n= 19, AbCS	0 0%
Mon 100, n= 7, AbNCS	2 2%
Mon 100, n= 7, AbCS	0 0%
Mon 104, n= 1, AbNCS	1 1%
Mon 104, n= 1, AbCS	0 0%
Mon 108, n= 10, AbNCS	2 2%
Mon 108, n= 10, AbCS	0 0%

25. Primary Outcome

Title	Number of Participants With Pigmentation of Non-retinal Ocular Tissue
Description	The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of all non-retinal ocular tissues. Only those participants available at the specified time points were analyzed.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	36
Number [Participants]	11 10.8%

26. Primary Outcome

Title	Number of Participants With Pigmentation of Retinal Ocular Tissue
Description	The ophthalmologist/retina specialist determined the presence or absence of abnormal discoloration of retinal ocular tissues. It included Pigmentary abnormalities in the macula, of peripheral retina as well as in both of them.. Only those participants available at the specified time points were analyzed.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	36
Number [Participants]	14 13.7%

27. Primary Outcome

Title	Number of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa
Description	An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 4 monthly study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids,lips, nails, and mucosa
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Any abnormal dermatologic discoloration	23 22.5%
Abnormal discoloration of skin	15 14.7%
Abnormal discoloration of lips	16 15.7%
Abnormal discoloration of nails	21 20.6%
Abnormal discoloration of mucosa	17 16.7%
Abnormal discoloration of sun-exposed tissue	22 21.6%
Abnormal discoloration of non su-exposed tissue	18 17.6%

28. Primary Outcome

Title	Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination
Description	A comprehensive eye examination was conducted by retina specialist or general ophthalmologist to assess best corrected visual acuity. An initial comprehensive eye examination was completed by an ophthalmologist for all participants. This exam was not associated with a specific visit. Thereafter, eye examinations was performed approximately every 6 months. Eye examination was introduced following protocol amendment and was conducted in all participants. Participants discontinued before implementation of this amendment and who have not had a comprehensive eye examination and skin examination (and follow-up by a dermatologist, if clinically indicated) were asked to return to the clinic for an evaluation of their skin (and follow-up dermatology examination, if clinically indicated) and for a comprehensive eye examination. Number of Par. with both initial and at least one follow-up exam while on RTG treatment were analyzed.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	24
Number [Participants]	2 2%

29. Primary Outcome

Title	Number of Participants With a Decrease in Confrontational Visual Field From Initial Examination
Description	Decrease in confrontation visual field is defined as a participant having a normal initial exam and an abnormal exam thereafter or, a response of clinically significant worsening in either eye since the last assessment.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Number [Participants]	0 0%

30. Primary Outcome

Title	Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine
Description	The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.
Time Frame	2 years and 9 months

Outcome Measure Data

Analysis Population Description

All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.

Arm/Group Title	Retigabine SFUCP
Arm/Group Description	Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Measure Participants	19
Retinal pigmentary abnormality	1 1%
Pigmentary abnormality of macula	1 1%
Pigmentary abnormality of peripheral retina	3 2.9%
Non-retinal ocular pigmentary abnormality	4 3.9%

31. Primary Outcome

Title	Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine
Description	An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.
Time Frame	2 years 9 months

Outcome Measure Data

Analysis Population Description

All SFUCP Subjects Population

Arm/Group Title	Retigabine SFUCP
Arm/Group Description	Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Measure Participants	19
Number [Participants]	1 1%

32. Primary Outcome

Title	Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation
Description	Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.
Time Frame	2 years 9 months

Outcome Measure Data

Analysis Population Description

All SFUCP Subjects Population

Arm/Group Title	Retigabine SFUCP
Arm/Group Description	Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Measure Participants	19
Retinal Pigmentary Abnormality, n=1	317.0
Pigmentary Abnormality of Macula, n=1	163.0
Pigmentary Abnormality of Peripheral Retina, n=3	317.0
Non-Retinal Ocular Pigmentary Abnormality, n=4	180.0

33. Primary Outcome

Title	Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration
Description	Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.
Time Frame	2 years 9 months

Outcome Measure Data

Analysis Population Description

All SFUCP Subjects Population

Arm/Group Title	Retigabine SFUCP
Arm/Group Description	Participants who withdraw from retigabine and who were found to have abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Measure Participants	19
All, n=1	439.0
Skin, n=5	347.0
Lips, n=4	284.5
Nails,n=7	377.0
Mucosa, n=3	468.0

34. Secondary Outcome

Title	Percentage Change From Baseline in the 28-day Partial Seizure
Description	Twenty-eight-day total partial seizure frequency during the study is defined as the sum of total partial seizures from First date (Baseline visit date +1 if no seizures on Baseline or Baseline visit date if seizures reported on the Baseline) to Last date (last visit date for seizure record with non-missing response), divided by applicable days, standardized by 28 days. The applicable days are the days in which the subject had non-missing seizure data. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	179
Mean (Standard Deviation) [Percent change]	-34.2 (68.70)

35. Secondary Outcome

Title	Number of Responders
Description	A participant was classified as a responder if there is an at least 50% reduction from Baseline in the 28-day total Partial Seizure frequency. Baseline was defined as the parent study Baseline. Only those participants available at the specified time points were analyzed.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	179
Number [Participants]	98 96.1%

36. Secondary Outcome

Title	Number of Participants Who Were Seizure Free for Any 6 Continuous Months
Description	Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Duration of exposure is defined using a window range allowed for each scheduled visit. At least 6 months of exposure is defined as >= 173 days of exposure since the window range for Month 6 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	140
Number [Participants]	20 19.6%

37. Secondary Outcome

Title	Number of Participants Who Were Seizure Free for Any 12 Continuous Months
Description	Duration of exposure is defined using a window range allowed for each scheduled visit. At least 12 months of exposure is defined as >= 353 days of exposure since the window range for Month 12 visit is +/- 7 days. Only those participants available at the specified time points were analyzed.
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	112
Number [Participants]	14 13.7%

38. Secondary Outcome

Title	Percentage of Seizure-free Days
Description	Number of seizure free days is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a participant had non-missing seizure data was considered as applicable days
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	179
Mean (Standard Deviation) [Percentage of days]	75.7 (25.92)

39. Secondary Outcome

Title	Change From Baseline in Quality of Life in Epilepsy (QOLIE)-31-P Questionnaire
Description	The QOLIE-31-P (Version 2.0) was utilized to assess quality of life. The QOLIE-31-P assessment was completed by the participants at Baseline, Month 3, Month 6, Month 9, Month 12 and annually after Month 12. The QOLIE has 7 sub scales as energy fatigue, emotional well being, social functioning, cognitive, medication effects, seizure worry and overall QOL. The assessment range for the overall score and the sub-scales is 0-100, where higher scores indicate greater well being. Change from Baseline was calculated as post-Baseline value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Time Frame	Assessed up to a maximum of 9 years

Outcome Measure Data

Analysis Population Description

Safety Population

Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
Measure Participants	181
Mon 3, n= 133	-2 (12.992)
Mon 6, n= 130	-2.95 (12.729)
Mon 9, n= 114	-1.65 (13.074)
Mon 12, n= 156	-2.77 (13.616)
Mon 24, n= 102	-3.13 (13.602)
Mon 36, n= 81	-2.43 (13.925)
Mon 48, n= 74	-1.05 (12.605)
Mon 60, n= 60	-0.41 (13.309)
Mon 72, n= 49	-0.35 (14.382)
Mon 84, n= 28	0.19 (14.699)
Mon 96, n= 18	-0.25 (17.986)
Mon 108, n= 11	1.55 (18.768)

Adverse Events

Time Frame	SAEs and non-serious AEs were collected from 1st dose of study medication in the OLE until 30 days after stopping study drug. Any AEs from parent study that worsened during the OLE are also captured (Assessed up to a maximum of 9 years).
Adverse Event Reporting Description	SAEs and non-serious AEs were assessed in the Safety Population
Arm/Group Title	Overall Study
Arm/Group Description	Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
All Cause Mortality
	Overall Study
	Affected / at Risk (%)	# Events
Total	1/181 (0.6%)
Serious Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	48/181 (26.5%)
Blood and lymphatic system disorders
Thrombocytopenia	1/181 (0.6%)
Cardiac disorders
Angina unstable	1/181 (0.6%)
Gastrointestinal disorders
Small intestinal obstruction	2/181 (1.1%)
Abdominal adhesions	1/181 (0.6%)
Neutropenic Colitis	1/181 (0.6%)
Gastritis	1/181 (0.6%)
General disorders
Idiosyncratic drug reaction	1/181 (0.6%)
Hepatobiliary disorders
Bile duct obstruction	1/181 (0.6%)
Biliary colic	1/181 (0.6%)
Cholecystitis	1/181 (0.6%)
Infections and infestations
Pneumonia	6/181 (3.3%)
Urinary tract infection	3/181 (1.7%)
Anal abscess	1/181 (0.6%)
Appendicitis perforated	1/181 (0.6%)
Gastroenteritis	1/181 (0.6%)
Injury, poisoning and procedural complications
Toxicity to various agents	2/181 (1.1%)
Ankle fracture	1/181 (0.6%)
Burns second degree	1/181 (0.6%)
Facial bones fracture	1/181 (0.6%)
Hand fracture	1/181 (0.6%)
Head injury	1/181 (0.6%)
Humerus fracture	1/181 (0.6%)
Jaw fracture	1/181 (0.6%)
Joint injury	1/181 (0.6%)
Laceration	1/181 (0.6%)
Lower limb fracture	1/181 (0.6%)
Overdose	1/181 (0.6%)
Postoperative ileus	1/181 (0.6%)
Radius fracture	1/181 (0.6%)
Splenic injury	1/181 (0.6%)
Investigations
Clostridium test positive	1/181 (0.6%)
Liver function test abnormal	1/181 (0.6%)
Transaminases increased	1/181 (0.6%)
Metabolism and nutrition disorders
Hypoglycaemia	1/181 (0.6%)
Musculoskeletal and connective tissue disorders
Back pain	1/181 (0.6%)
Neck pain	1/181 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland	1/181 (0.6%)
Breast cancer	1/181 (0.6%)
Fibroadenoma of breast	1/181 (0.6%)
Insulinoma	1/181 (0.6%)
Parathyroid tumour benign	1/181 (0.6%)
Nervous system disorders
Seizure	4/181 (2.2%)
Epilepsy	2/181 (1.1%)
Cerebrovascular accident	1/181 (0.6%)
Headache	1/181 (0.6%)
Hemiparesis	1/181 (0.6%)
Lumbar radiculopathy	1/181 (0.6%)
Partial seizures with secondary generalisation	1/181 (0.6%)
Postictal state	1/181 (0.6%)
Psychomotor hyperactivity	1/181 (0.6%)
Seizure cluster	1/181 (0.6%)
Status epilepticus	1/181 (0.6%)
Subarachnoid haemorrhage	1/181 (0.6%)
Tonic convulsion	1/181 (0.6%)
Psychiatric disorders
Confusional state	1/181 (0.6%)
Conversion disorder	1/181 (0.6%)
Depression	1/181 (0.6%)
Epileptic psychosis	1/181 (0.6%)
Major depression	1/181 (0.6%)
Mental status changes	1/181 (0.6%)
Nervousness	1/181 (0.6%)
Somatic Symptom Disorder	1/181 (0.6%)
Renal and urinary disorders
Urinary retention	3/181 (1.7%)
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/181 (0.6%)
Epistaxis	1/181 (0.6%)
Other (Not Including Serious) Adverse Events
	Overall Study
	Affected / at Risk (%)	# Events
Total	169/181 (93.4%)
Ear and labyrinth disorders
Vertigo	11/181 (6.1%)
Eye disorders
Retinal pigmentation	11/181 (6.1%)
Vision blurred	11/181 (6.1%)
Diplopia	10/181 (5.5%)
Gastrointestinal disorders
Oral mucosal discolouration	21/181 (11.6%)
Abdominal pain	18/181 (9.9%)
Diarrhoea	16/181 (8.8%)
Lip discolouration	16/181 (8.8%)
Pigmentation lip	15/181 (8.3%)
Vomiting	15/181 (8.3%)
Constipation	14/181 (7.7%)
Nausea	14/181 (7.7%)
Toothache	13/181 (7.2%)
Abdominal pain upper	10/181 (5.5%)
General disorders
Fatigue	20/181 (11%)
Infections and infestations
Influenza	28/181 (15.5%)
Viral Upper Respiratory Tract Infection	10/181 (5.5%)
Sinusitis	12/181 (6.6%)
Injury, poisoning and procedural complications
Contusion	17/181 (9.4%)
Laceration	11/181 (6.1%)
Musculoskeletal and connective tissue disorders
Back pain	18/181 (9.9%)
Pain in extremity	12/181 (6.6%)
Arthralgia	10/181 (5.5%)
Nervous system disorders
Dizziness	55/181 (30.4%)
Somnolence	44/181 (24.3%)
Headache	42/181 (23.2%)
Tremor	22/181 (12.2%)
Seizure	16/181 (8.8%)
Dysarthria	17/181 (9.4%)
Paraesthesia	17/181 (9.4%)
Memory impairment	13/181 (7.2%)
Ataxia	12/181 (6.6%)
Amnesia	11/181 (6.1%)
Aphasia	11/181 (6.1%)
Speech disorder	10/181 (5.5%)
Psychiatric disorders
Anxiety	14/181 (7.7%)
Depression	13/181 (7.2%)
Confusional state	15/181 (8.3%)
Renal and urinary disorders
Urinary tract infection	37/181 (20.4%)
Urinary retention	11/181 (6.1%)
Urinary hesitation	10/181 (5.5%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection	16/181 (8.8%)
Skin and subcutaneous tissue disorders
Skin discolouration	19/181 (10.5%)
Nail discolouration	15/181 (8.3%)
Nail pigmentation	15/181 (8.3%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.