An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00372528
• Collaborator: (none)
• Enrollment: 21
• Locations: 5
• Arm: 1
• Duration (Months): 55
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this trial is to allow continued access to pregabalin to Canadian subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114 and 1008-164 and to continue to study the long term safety of pregabalin administered as adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with refractory partial seizures.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: pregabalin (LYRICA)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Multi-Center, Add-On Study Of Pregabalin (LYRICA) In Subjects With Refractory Partial Seizures Who Have Completed Studies 1008-010, 1008-035, 1008-114 Or 1008-164
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pregabalin open label treatment	Drug: pregabalin (LYRICA); 150 mg up to a maximum of 600 mg per day bid or tid as required

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Baseline up to Year 5 and follow-up (30 days after last dose)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Secondary Outcome Measures

1. Mean Number of Seizures [Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)]

   Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164 and wishes to continue receiving open-label pregabalin

• Must have responded favorably to pregabalin in Pfizer open-label study 1008-010, 1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator continued treatment with pregabalin is in the the patient's best medical interest

Exclusion Criteria:

• Is pregnant or is considering becoming pregnant during the course of the study

• Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035, 1008-114 or 1008-164

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Calgary	Alberta	Canada	T2N 2T9
2	Pfizer Investigational Site	Halifax	Nova Scotia	Canada	B3H 3A7
3	Pfizer Investigational Site	Barrie	Ontario	Canada	L4M 4S5
4	Pfizer Investigational Site	Toronto	Ontario	Canada	M5C 1R6
5	Pfizer Investigational Site	Windsor	Ontario	Canada	N8X 5A6

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: NCT00372528
• Other Study ID Numbers: A0081140
• First Posted: Sep 7, 2006
• Last Update Posted: Jan 26, 2021
• Last Verified: Sep 1, 2012

• Additional relevant MeSH terms: Seizures; Pregabalin

Study Results

Participant Flow

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Period Title: Overall Study
STARTED	21
COMPLETED	0
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Overall Participants	21
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	44.0 (12.6)
Sex: Female, Male (Count of Participants)
Female	12 57.1%
Male	9 42.9%
Mean Number of Seizures (Seizures) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Seizures]	30.70 (40.63)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline up to Year 5 and follow-up (30 days after last dose)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set (SAS) included all participants who had received at least 1 dose of study medication in the open label period.

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Measure Participants	21
AEs	21 100%
SAEs	3 14.3%

2. Secondary Outcome

Title	Mean Number of Seizures
Description	Seizures were episodes of disturbed brain activity that cause changes in attention or behavior. The different types of seizures observed were complex partial, secondarily generalized tonic-clonic, simple partial and others. Mean number of seizures were calculated between each study visit.
Time Frame	Month 6 thereafter every 6 months up to Month 54 or End of Study (EOS) and follow-up (30 days after last dose)

Outcome Measure Data

Analysis Population Description

SAS included all participants who had received at least 1 dose of study medication in the open label period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. Here, 'n' signifies those participants who were evaluable between each visit.

Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
Measure Participants	20
Month 6 to Month 12 (n = 20)	35.10 (46.92)
Month 12 to Month 18 (n = 18)	29.70 (26.05)
Month 18 to Month 24 (n = 19)	27.80 (28.75)
Month 24 to Month 30 (n = 18)	32.50 (33.91)
Month 30 to Month 36 (n = 18)	29.30 (29.13)
Month 36 to Month 42 (n = 17)	28.70 (28.38)
Month 42 to Month 48 (n = 11)	24.80 (32.99)
Month 54 or EOS (n = 19)	22.90 (24.57)
Follow-up (n = 14)	6.40 (6.39)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Pregabalin
Arm/Group Description	Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator's discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
All Cause Mortality
	Pregabalin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pregabalin
	Affected / at Risk (%)	# Events
Total	3/21 (14.3%)
Infections and infestations
Lung infection	1/21 (4.8%)
Urinary tract infection	1/21 (4.8%)
Injury, poisoning and procedural complications
Overdose	1/21 (4.8%)
Nervous system disorders
Grand mal convulsion	1/21 (4.8%)
Other (Not Including Serious) Adverse Events
	Pregabalin
	Affected / at Risk (%)	# Events
Total	21/21 (100%)
Blood and lymphatic system disorders
Thrombocytopenia	1/21 (4.8%)
Cardiac disorders
Cyanosis	1/21 (4.8%)
Myocardial infarction	1/21 (4.8%)
Ear and labyrinth disorders
Cerumen impaction	1/21 (4.8%)
Deafness	1/21 (4.8%)
Tympanic membrane perforation	1/21 (4.8%)
Eye disorders
Visual acuity reduced	1/21 (4.8%)
Gastrointestinal disorders
Diarrhoea	2/21 (9.5%)
Gastrooesophageal reflux disease	2/21 (9.5%)
Haematochezia	1/21 (4.8%)
Nausea	1/21 (4.8%)
Toothache	1/21 (4.8%)
Vomiting	2/21 (9.5%)
General disorders
Asthenia	1/21 (4.8%)
Influenza like illness	1/21 (4.8%)
Malaise	1/21 (4.8%)
Infections and infestations
Ear infection	1/21 (4.8%)
Herpes zoster	1/21 (4.8%)
Labyrinthitis	1/21 (4.8%)
Nasopharyngitis	2/21 (9.5%)
Otitis externa	1/21 (4.8%)
Pneumonia	1/21 (4.8%)
Upper respiratory tract infection	1/21 (4.8%)
Urinary tract infection	1/21 (4.8%)
Wound infection	1/21 (4.8%)
Injury, poisoning and procedural complications
Back injury	1/21 (4.8%)
Epicondylitis	1/21 (4.8%)
Excoriation	1/21 (4.8%)
Fall	10/21 (47.6%)
Foetal exposure during pregnancy	1/21 (4.8%)
Foot fracture	2/21 (9.5%)
Hand fracture	1/21 (4.8%)
Head injury	2/21 (9.5%)
Joint injury	1/21 (4.8%)
Laceration	4/21 (19%)
Limb injury	1/21 (4.8%)
Scratch	1/21 (4.8%)
Thermal burn	1/21 (4.8%)
Toxicity to various agents	1/21 (4.8%)
Investigations
Blood alkaline phosphatase increased	1/21 (4.8%)
Blood iron decreased	1/21 (4.8%)
Electrocardiogram abnormal	2/21 (9.5%)
Liver function test abnormal	1/21 (4.8%)
Vitamin B12 decreased	1/21 (4.8%)
Vitamin D decreased	1/21 (4.8%)
Weight decreased	2/21 (9.5%)
Weight increased	3/21 (14.3%)
Metabolism and nutrition disorders
Diabetes mellitus	1/21 (4.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/21 (9.5%)
Back pain	1/21 (4.8%)
Joint swelling	1/21 (4.8%)
Neck pain	1/21 (4.8%)
Osteoarthritis	1/21 (4.8%)
Osteoporosis	1/21 (4.8%)
Pain in extremity	4/21 (19%)
Nervous system disorders
Balance disorder	1/21 (4.8%)
Carotid artery occlusion	1/21 (4.8%)
Convulsion	2/21 (9.5%)
Dizziness	1/21 (4.8%)
Headache	4/21 (19%)
Lethargy	1/21 (4.8%)
Memory impairment	1/21 (4.8%)
Somnolence	1/21 (4.8%)
Tremor	1/21 (4.8%)
Psychiatric disorders
Anger	1/21 (4.8%)
Anxiety	2/21 (9.5%)
Confusional state	1/21 (4.8%)
Depression	3/21 (14.3%)
Insomnia	1/21 (4.8%)
Mood altered	1/21 (4.8%)
Panic attack	1/21 (4.8%)
Stress	2/21 (9.5%)
Suicidal ideation	1/21 (4.8%)
Reproductive system and breast disorders
Dysmenorrhoea	1/21 (4.8%)
Vaginal haemorrhage	1/21 (4.8%)
Respiratory, thoracic and mediastinal disorders
Asthma	1/21 (4.8%)
Cough	1/21 (4.8%)
Vascular disorders
Hypertension	1/21 (4.8%)

Limitations/Caveats

This was a compassionate use study and no formal primary outcome measure was specified a priori. Descriptive safety data were collected, subsequently safety outcome was designated as primary outcome as per National Institute of Health (NIH) criteria.

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.