The primary endpoint was the log e-transformed 28 day seizure rate for all partial onset seizures collected during the double-blind treatment phase compared to the 8 week baseline (screening) seizure period.The analysis of the primary endpoint, log e (28-days seizure rate + 1), showed a non-significant result between pregabalin and placebo for the pregabalin CR 330 mg group (p=0.0907). Responder rates, defined as the percentage of patients with a ≥ 50% reduction in seizure frequency from baseline, were 45.9%, 37.8% and 35.8% for the CR 330 mg, CR 165 mg, and placebo groups, respectively, and highlight the high placebo response observed in this study.
Pfizer Reports Top-Line Results Of A Phase 3 Study Evaluating Pregabalin Controlled-Release Formulation As Adjunctive Treatment In Adult Patients With Partial Onset Seizures
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