Pregabalin monotherapy in patients with partial-onset seizures A historical-controlled trial
Jacqueline French, Patrick Kwan, Toufic Fakhoury, Verne Pitman, Sarah DuBrava, Lloyd Knapp, Lorraine Yurkewicz
Neurology | LIPPINCOTT WILLIAMS & WILKINS | Published : 2014
OBJECTIVE: To assess pregabalin monotherapy for partial-onset seizures using a historical-controlled conversion-to-monotherapy design. METHODS: Adults with inadequately controlled partial-onset seizures while receiving 1 or 2 antiepileptic drugs during an 8-week prospective baseline were randomized to double-blind monotherapy with pregabalin 600 or 150 mg/d (4:1) for 20 weeks (8-week conversion and 12-week monotherapy period). The primary endpoint was the seizure-related exit rate for pregabalin 600 mg/d, based on discontinuations due to predefined criteria. Efficacy was declared if the upper limit of the 95% confidence interval for the exit rate was below a historical-control threshold of 7..View full abstract
This study was funded by Pfizer Inc. Editorial support with the collation of author comments and proofreading of the manuscript was provided by Elizabeth Harvey, PhD, of Engage Scientific Solutions, and funded by Pfizer Inc.