Overview

A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.

Status:
Completed

Trial end date:
2018-03-13

Target enrollment:

Participant gender:

Summary

This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures. It is hypothesized that both doses of pregabalin will demonstrate superior efficacy when compared to placebo by reducing the partial onset 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