CTRI/2011/08/001976
Completed
Phase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial Of Pregabalin Controlled Release Formulation As Adjunctive Therapy In Adults With Partial Onset Seizures - Protocol A0081194 - Not Applicable
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer Limited
- Enrollment
- 264
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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