Once-A-Day Pregabalin For Partial Seizures
Phase 3
Completed
- Conditions
- Health Condition 1: null- Partial SeizuresEpilepsies, Partial
- Registration Number
- CTRI/2011/08/001976
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 264
Inclusion Criteria
1.Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
2.Currently taking 1 to 3 anti-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs . subjects need to have 6 seizures during the 8 week screening period with no 4 week period with zero seizures
In India as per DCGI Directive, subjects aged greater than equal to 18 years and les than equal to 65 years should be enrolled in the study
Exclusion Criteria
1.Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
2.Status epilepticus within one year prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method