Overview

A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.

Status:
Completed

Trial end date:
2019-02-20

Target enrollment:

Participant gender:

Summary

The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo. It is hypothesized that both doses of pregabalin will demonstrated superior efficacy when compared to placebo by reducing PGTC seizure frequency and that pregabalin will be safe and well tolerated.

Phase:

Phase 3

Details

Lead Sponsor:

Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatments:

Pregabalin