Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial.

ABSTRACT:

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 74%, with stepwise evaluation using a threshold of 68%.

Results

The trial was sto

SUBMITTER: French J 

PROVIDER: S-EPMC3963419 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature