| Once-A-Day Pregabalin For Partial Seizures |
| 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 |
| Approximately 30% percent of subjects with partial seizures are refractory to treatment with single or combination antiepileptic drugs. The present study will compare the efficacy of two different dosages of pregabalin CR dosed once daily as compared to placebo, when used as adjunctive therapy in subjects requiring adjunctive therapy for partial onset epilepsy, using a randomized, parallel group design. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
- Partial Seizures
- Epilepsies, Partial
|
- Drug: pregabalin
Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
- Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
- Drug: pregabalin
Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
- Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
- Drug: pregabalin
Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
- Drug: placebo
matched to the active drug
|
|
|
| Not Provided |
| |
| Completed |
| 334 |
| August 2012 |
| August 2012 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Diagnosis of epilepsy with partial onset seizures (seizures may be simple or complex, with or without evolution into a bilateral, convulsive seizure)
- Currently taking 1 to 3 anit-epilepsy medicines (AEDs) at stable dosages, and who have taken at least 2 prior (or ongoing) AEDs
Exclusion Criteria:
- Primary generalized seizures (for example, absence, myoclonic seizures or Lennox-Gastaut Syndrome)
- Status epilepticus within one year prior to screening
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Bosnia and Herzegovina, Bulgaria, Czech Republic, Germany, Hong Kong, Hungary, India, Malaysia, Mexico, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Thailand, United States |
| Croatia, South Africa |
| |
| NCT01262677 |
| A0081194 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| September 2013 |
