Overview

A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures

Status:
Completed

Trial end date:
2007-10-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of topiramate in infants aged 1-24 months with refractory partial-onset seizures. Topiramate is an antiepileptic drug approved for use in adult and pediatric patients (aged 2 to 16 years) with refractory partial onset seizures (POS) with or without secondarily generalized seizures, primary generalized tonic clonic seizures, or Lennox-Gastaut syndrome (LGS).

Phase:

Phase 1

Details

Lead Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Treatments:

Topiramate