A phase 3 study assessing the use pregabalin as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint to reduce seizure frequency compared with placebo, according to Pfizer.
The 12-week randomized, double-blind, placebo-controlled, multicenter study was conducted at 70 sites in 21 countries and included 219 patients. Patients were randomized in a 1:1:1 ratio to receive placebo, or 1 of 2 fixed doses of pregabalin twice daily. The primary endpoint was the percent reduction of 28 day seizure rate for all PGTC seizures relative to placebo.
Findings from the phase 3 study showed that treatment with pregabalin for PGTC seizures did not result in a statistically significant reduction in seizure frequency versus placebo.
“Pfizer is committed to the study of patient populations with unmet treatment needs, including pediatric and adult patients experiencing generalized tonic-clonic seizures,” said Juan Ovalle, MD, Global Chief Medical Officer, R&D and Medical, Upjohn, a division of Pfizer. “These data contribute to our growing understanding of pediatric epilepsy and reflect our responsibility to advance scientific knowledge through post-marketing research.”
For more information visit pfizer.com.