Non-Interventional Study With LYRICA (Pregabalin) In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00684424
• Collaborator: (none)
• Enrollment: 199
• Duration (Months): 8

Study Details

Study Description

Brief Summary

The primary efficacy parameter will be the responder rate, defined as the proportion of subjects who had at least a 50% reduction in 28 day seizure rate during the maintenance phase

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Other: Non-Interventional Study

Study Design

• Study Type: Observational
• Actual Enrollment: 199 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Non-Interventional Study (NIS) With Lyrica In Patients With Epilepsy As Adjunctive Therapy Of Partial Seizures To Reduce Seizure Frequency
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Outpatients with epilepsy	Other: Non-Interventional Study; Observational Only

Outcome Measures

Primary Outcome Measures

1. Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency [Baseline through Week 16]

   Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.

Secondary Outcome Measures

1. Antiepileptic Drugs Used in the Past [Baseline]

   Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.

2. Change in 28 Day Partial Seizure Frequency [Baseline through Week 16 (Final Visit )]

   Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.

3. Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study [Week 8 up to Week 16 (Last 4 weeks of the treatment period)]

   Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.

4. Concomitant Drug Treatments [Baseline through Week 16 (Final Visit)]

   Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.

5. Average Dosage of Pregabalin Taken at Baseline and Final Visit [Baseline, Week 16 (Final Visit )]

   Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.

6. Visual Analog Scale of Anxiety (VAS-A) [Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward]

   Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.

7. Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A) [Baseline, Week 16 (Final Visit), Last Observation Carried Forward]

   Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.

8. Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S) [Baseline]

   CGI-S scale: physician's global impression of a subject's clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.

9. Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C) [Week 16 (Final Visit)]

   CGI-C scale: physician's global impression of a subject's clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.

10. Medical Outcomes Sleep Scale (MOS-S) [Baseline, Week 16 (Final Visit )]

    MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.

11. Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale [Baseline, Week 16 (Final Visit)]

    MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age over 18 years old, patients with epilepsia with partial seizures

• Enrollment to study is fully on physician decision in compliance with current SPC.

Exclusion Criteria:

• Patient who did not meet indication according to SPC Lyrica

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00684424
• Other Study ID Numbers: A0081213
• First Posted: May 26, 2008
• Last Update Posted: Feb 10, 2021
• Last Verified: May 1, 2010

• Additional relevant MeSH terms: Epilepsy; Seizures

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 36 medical centers and participated in the study between 11 July 2008 and 30 March 2009.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Period Title: Overall Study
STARTED	199
COMPLETED	194
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Overall Participants	199
Age, Customized (participants) [Number]
<=18 years	2 1%
18 - 44 years	104 52.3%
45 - 65 years	60 30.2%
>= 65 years	33 16.6%
Sex: Female, Male (Count of Participants)
Female	107 53.8%
Male	92 46.2%

Outcome Measures

1. Primary Outcome

Title	Responders: Number of Subjects With a 50% or Greater Reduction in Seizure Frequency
Description	Responders: number of subjects with a 50 percent (%) or greater reduction in partial seizure frequency from Baseline to Final visit. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in the maintenance treatment phase. Missing category includes subjects with missing attack date, insufficient length of treatment period or no seizures in both baseline and treatment periods. Subjects with zero seizures in the baseline period and some seizures in the treatment period were treated as non-responders.
Time Frame	Baseline through Week 16

Outcome Measure Data

Analysis Population Description

Full Analysis Set: all subjects who received at least 1 dose of study drug and had at least 1 efficacy measurement.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Responders	138 69.3%
Non-Responders	44 22.1%
Missing	17 8.5%

2. Secondary Outcome

Title	Antiepileptic Drugs Used in the Past
Description	Antiepileptic drug history: number of subjects who took each class of antiepileptic drug prior to entering the study. Subjects who took more than one antiepileptic drug were counted for each of the drug classes.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Safety analysis set: all subjects who received at least 1 dose of study medication.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Barbiturates	42 21.1%
Carbamazepine	93 46.7%
Gabapentin	30 15.1%
Lamotrigine	38 19.1%
Levetiracetam	26 13.1%
Phenytoin	66 33.2%
Tiagabine	4 2%
Topiramate	40 20.1%
Valproate	97 48.7%
Vigabatrine	4 2%
Other	16 8%
Missing	9 4.5%
No previous treatment	11 5.5%

3. Secondary Outcome

Title	Change in 28 Day Partial Seizure Frequency
Description	Change in 28-day partial seizure frequency between the baseline period and treatment period. Baseline period = the 4 weeks (28 days) prior to Baseline visit. Treatment period = last 12 weeks (84 days) of the study (maintenance treatment phase excluding 4-week titration phase). Seizure frequency in baseline period = total number of partial seizures in baseline phase * 28 divided by total number of days in the baseline phase. Seizure frequency in treatment period = total number of partial seizures in maintenance treatment phase * 28 divided by total number of days in maintenance treatment phase.
Time Frame	Baseline through Week 16 (Final Visit )

Outcome Measure Data

Analysis Population Description

FAS. Subjects who discontinued less than 4 weeks into the treatment period or with missing date of the attack were excluded from analyses.

Arm/Group Title	Pregabalin
Arm/Group Description
Measure Participants	196
Baseline Period	3.20 (3.375)
Treatment Period	1.339 (2.5177)
Change from Baseline to Treatment Period	-1.860 (2.0494)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pregabalin (Lyrica)
	Comments	R-ratio of seizure frequency summaries = [(t-b)/(t+b)]*100; where t= treatment seizure frequency and b= baseline seizure frequency.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	R-ratio
	Estimated Value	-56.723
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 46.9499
	Estimation Comments

4. Secondary Outcome

Title	Seizure Freedom: Number of Seizure-free Subjects During the Last 4 Weeks of the Study
Description	Seizure Freedom (responders): subjects with no seizures (partial or other) during the last 4 weeks of the study. Non-responders: subjects with seizures (partial or other)during the last 4 weeks of the study. Subjects, who discontinued less than 4 weeks into the observation period were excluded from analysis. The 4 week period excludes the titration phase of the study. Missing category includes subjects with missing attack date or insufficient length of treatment period.
Time Frame	Week 8 up to Week 16 (Last 4 weeks of the treatment period)

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Responders: Seizure-free	119 59.8%
Non-responders: With Seizures	77 38.7%
Missing	3 1.5%

5. Secondary Outcome

Title	Concomitant Drug Treatments
Description	Concomitant drugs treatments (drugs other than, and in addition to study medication): number of subjects who took each concomitant drug during the study (baseline through end of study). World Health Organization (WHO) Drug (v02Q2) coding dictionary applied.
Time Frame	Baseline through Week 16 (Final Visit)

Outcome Measure Data

Analysis Population Description

Safety analysis set.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Acetylsalicylic acid	2 1%
Acidum folicum	1 0.5%
Alendronic acid	1 0.5%
Alprazolam	2 1%
Amlodipine besilate	1 0.5%
Amlozek	1 0.5%
Anopyrin	3 1.5%
Atorvastatin calcium	1 0.5%
Aurorix	1 0.5%
Biston	1 0.5%
Carbamazepine	26 13.1%
Cipralex	1 0.5%
Citalopram	2 1%
Citalopram hydrobromide	1 0.5%
Clonazepam	6 3%
Colecalciferol	1 0.5%
Depakine	10 5%
Depakine chrono	14 7%
Detralex	1 0.5%
Diarel	1 0.5%
Diazepam	1 0.5%
Dipyridamole	1 0.5%
Enelbin - slow release	1 0.5%
Euthyrox	2 1%
Felodipine/ramipril	1 0.5%
Fenytoin	1 0.5%
Fluanxol depot	1 0.5%
Gabapentin	3 1.5%
Gabitril	1 0.5%
Geratam	1 0.5%
Ginko biloba	1 0.5%
Glibenclamide	1 0.5%
Glucobene	1 0.5%
Godasal	2 1%
Hypnogen	1 0.5%
Keppra	20 10.1%
Lamictal	18 9%
Lamotrigine	49 24.6%
Letrox	2 1%
Levetiracetam	20 10.1%
Levothyroxine	2 1%
Lexaurin	1 0.5%
Lipanthyl	2 1%
Lispril	1 0.5%
Liskantin	4 2%
Lokren	1 0.5%
Lusopress	1 0.5%
Magnesium	1 0.5%
Magnesium lactate	2 1%
Metformin	1 0.5%
Metoprolol	1 0.5%
Micardis	2 1%
Neurontin	1 0.5%
Neurotop	3 1.5%
Neurotop - slow release	5 2.5%
Omeprazol	1 0.5%
Omeprazole	1 0.5%
Paroxetine	1 0.5%
Pentomer	1 0.5%
Perindopril	1 0.5%
Perindopril erbumine	1 0.5%
Phenytoin	4 2%
Piracetam	2 1%
Prestarium	5 2.5%
Primdone	2 1%
Ramipril	1 0.5%
Ramipril/hydrochlorothiazide	1 0.5%
Rivotril	8 4%
Rufinamide	1 0.5%
Sabril	1 0.5%
Sanepil	1 0.5%
Seretide diskus	1 0.5%
Sertraline	1 0.5%
Simepar	1 0.5%
Simvastatin	1 0.5%
Siofor	1 0.5%
Sodanton	1 0.5%
Sorbimon	1 0.5%
Sumatriptan	1 0.5%
Symbicort turbuhaler "Draco"	1 0.5%
Tegretol	2 1%
Tegretol CR	8 4%
Ticlopidine	3 1.5%
Timonil	1 0.5%
Timonil - slow release	8 4%
Topamax	15 7.5%
Topiramate	25 12.6%
Trandlapril	1 0.5%
Valproate	22 11.1%
Valproate sodium	7 3.5%
Valproic acid	14 7%
Vasocardin	1 0.5%
Vinpocetine	1 0.5%
Warfarin	1 0.5%
Zocor	2 1%
Zoloft	1 0.5%

6. Secondary Outcome

Title	Average Dosage of Pregabalin Taken at Baseline and Final Visit
Description	Average doses of pregabalin in milligrams per day (mg/day) taken at baseline and final visit shown by number of participants at each dose.
Time Frame	Baseline, Week 16 (Final Visit )

Outcome Measure Data

Analysis Population Description

Safety analysis set.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Baseline: 75 mg	31 15.6%
Baseline:100 mg	0 0%
Baseline: 130 mg	1 0.5%
Baseline: 150 mg	166 83.4%
Baseline: 225 mg	0 0%
Baseline: 300 mg	1 0.5%
Baseline: 375 mg	0 0%
Baseline: 450 mg	0 0%
Baseline: 525 mg	0 0%
Baseline: 600 mg	0 0%
Final Visit: 75 mg	8 4%
Final Visit: 100 mg	1 0.5%
Final Visit: 130 mg	1 0.5%
Final Visit: 150 mg	55 27.6%
Final Visit: 225 mg	5 2.5%
Final Visit: 300 mg	89 44.7%
Final Visit: 375 mg	1 0.5%
Final Visit: 450 mg	6 3%
Final Visit: 525 mg	1 0.5%
Final Visit: 600 mg	32 16.1%

7. Secondary Outcome

Title	Visual Analog Scale of Anxiety (VAS-A)
Description	Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety at each visit.
Time Frame	Baseline, Week 4, Week 16 (Final Visit), Last Observation Carried Forward

Outcome Measure Data

Analysis Population Description

FAS; Last observation carried forward (LOCF) method: subject's last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Baseline (n=197)	47.1 (21.52)
Week 4 (Visit 2 ) (n=196)	36.7 (18.43)
Week 16 (Final Visit ) (n=197)	29.0 (17.05)
Last Observation Carried Forward (LOCF) (n=198)	29.0 (17.03)

8. Secondary Outcome

Title	Change From Baseline to Final Visit in Visual Analog Scale of Anxiety (VAS-A)
Description	Visual Analog Scale of anxiety self assessment: metric measurement (in 2 mm interval) from the visual analog scale; 0 mm = no anxiety, 100 mm = extreme anxiety. Change from Baseline to Final Visit: score at final visit minus score at baseline.
Time Frame	Baseline, Week 16 (Final Visit), Last Observation Carried Forward

Outcome Measure Data

Analysis Population Description

FAS; Last observation carried forward (LOCF) method: subject's last available post-baseline observation was used if data were missing. In this case, data from Visit 2 were carried forward if final visit data were missing.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Change from Baseline to Week 16 (n=196)	-18.2 (17.61)
Change from Baseline to LOCF (n=197)	-18.1 (17.64)

9. Secondary Outcome

Title	Number of Subjects With Categorical Scores on Clinical Global Impression of Severity (CGI-S)
Description	CGI-S scale: physician's global impression of a subject's clinical condition, at baseline in terms of severity. Numerical scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill subjects). Numbers of subjects in each category are presented.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Normal, not at all ill	28 14.1%
Borderline mentally ill	77 38.7%
Mildly ill	39 19.6%
Moderately ill	31 15.6%
Markedly ill	14 7%
Severely ill	9 4.5%
Among the most extremely ill patients	1 0.5%

10. Secondary Outcome

Title	Number of Subjects With Categorical Scores on Clinical Global Impression of Change(CGI-C)
Description	CGI-C scale: physician's global impression of a subject's clinical condition in terms of change from baseline. Improvement = CGI response of very much improved, much improved, or minimally improved. No Change = CGI response of no change. Worsening = CGI response of very much worse, much worse or minimally worse.
Time Frame	Week 16 (Final Visit)

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Improvement	174 87.4%
No Change	21 10.6%
Worsening	2 1%
Missing	2 1%

11. Secondary Outcome

Title	Medical Outcomes Sleep Scale (MOS-S)
Description	MOS-S: subject reported measure with 12 items that assess key constructs of sleep over the past week. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = greater intensity of attribute.
Time Frame	Baseline, Week 16 (Final Visit )

Outcome Measure Data

Analysis Population Description

FAS. A subscale was classified as missing if any of the questions used in the calculation were missing. Abbreviations: BL = Baseline, SOB = short of breath.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
Baseline: Sleep Disturbance	37.86 (20.643)
Baseline: Snoring	29.1 (21.31)
Baseline: Awaken Short of Breath or With Headache	18.5 (19.26)
Baseline: Quantity of Sleep	7.0 (1.40)
Baseline: Sleep Adequacy	47.51 (24.336)
Baseline: Somnolence	35.99 (16.197)
Baseline: Sleep 6-Item Index	38.74 (17.522)
Baseline: Sleep 9-Item Index	38.82 (16.840)
Final Visit: Sleep Disturbance	25.21 (15.670)
Final Visit: Snoring	26.5 (21.86)
Final Vst: Awaken Short of Breath or With Headache	15.1 (16.68)
Final Visit: Quantity of Sleep	7.5 (1.31)
Final Visit: Sleep Adequacy	60.00 (22.113)
Final Visit: Somnolence	30.09 (15.398)
Final Visit: Sleep 6-Item Index	29.30 (14.501)
Final Visit: Sleep 9-Item Index	28.69 (13.399)
Change from BL: Sleep Disturbance	-13.07 (17.010)
Change from BL: Snoring	-2.9 (13.01)
Change from BL: Awaken SOB or Headache	-3.8 (13.55)
Change from BL: Quantity of Sleep	0.6 (1.23)
Change from BL: Sleep Adequacy	13.02 (19.636)
Change from BL: Somnolence	-6.18 (14.399)
Change from BL: Sleep 6-Item Index	-9.88 (13.641)
Change from BL: Sleep 9-Item Index	-10.54 (13.280)

12. Secondary Outcome

Title	Number of Subjects With Change in Response Categories in Medical Outcomes Sleep Scale (MOS-S): Optimal Sleep Subscale
Description	MOS: subject rated questionnaire to assess sleep quality and quantity. Optimal sleep subscale is derived from Sleep Quantity average hours of sleep each night during the past week. Number of subjects with response: YES (Optimal) if sleep quantity was 7 or 8 hours per night, or response = NO (Non-Optimal) if sleep quantity was less than (<) 7 hours per night. Number of participants with shift in response categories from Baseline to Final Visit.
Time Frame	Baseline, Week 16 (Final Visit)

Outcome Measure Data

Analysis Population Description

FAS. Abbreviations: BL = Baseline; FV = Final Visit.

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
Measure Participants	199
BL: Optimal Sleep; FV: Optimal Sleep	82 41.2%
BL: Optimal Sleep; FV: Non-Optimal Sleep	10 5%
BL: Optimal Sleep; FV: Missing	2 1%
BL: Non-Optimal Sleep; FV: Optimal Sleep	33 16.6%
BL: Non-Optimal Sleep; FV: Non-Optimal Sleep	48 24.1%
BL: Non-Optimal Sleep; FV: Missing	5 2.5%
BL: Missing; FV: Optimal Sleep	1 0.5%
BL: Missing; FV: Non-Optimal Sleep	2 1%
BL: Missing; FV: Missing	16 8%

Adverse Events

Arm/Group Title	Pregabalin (Lyrica)
Arm/Group Description	Individualized dose ranging from 150 mg to 600 mg daily administered as two single doses.
All Cause Mortality
	Pregabalin (Lyrica)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pregabalin (Lyrica)
	Affected / at Risk (%)	# Events
Total	1/199 (0.5%)
Nervous system disorders
Hemiplegia	1/199 (0.5%)
Other (Not Including Serious) Adverse Events
	Pregabalin (Lyrica)
	Affected / at Risk (%)	# Events
Total	26/199 (13.1%)
Ear and labyrinth disorders
Vertigo	2/199 (1%)
General disorders
Oedema peripheral	1/199 (0.5%)
Investigations
Weight increased	6/199 (3%)
Nervous system disorders
Dizziness	10/199 (5%)
Epilepsy	1/199 (0.5%)
Somnolence	6/199 (3%)
Psychiatric disorders
Anxiety	1/199 (0.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.