Journal article

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..

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