Progesterone vs placebo therapy for women with epilepsy: A randomized clinical trial.

ABSTRACT:

Objective

To assess progesterone treatment of intractable seizures in women with partial epilepsy.

Methods

This randomized, double-blind, placebo-controlled, phase III, multicenter, clinical trial compared the efficacy and safety of adjunctive cyclic natural progesterone therapy vs placebo treatment of intractable seizures in 294 subjects randomized 2:1 to progesterone or placebo, stratified by catamenial and noncatamenial status. It compared treatments on proportions of ≥50% responders and changes in seizure frequency from 3 baseline to 3 treated menstrual cycles.

Results

There was no significant difference in proportions of responders between progesterone and placebo in the catamenial and noncatamenial strata. Prespecified secondary analysis showed that the level of

SUBMITTER: Herzog AG 

PROVIDER: S-EPMC3369508 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature