A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures.

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Fixed Dose-Ranging Study to Assess the Safety, Tolerability, and Efficacy of Topiramate Oral Liquid and Sprinkle Formulations as an Adjunct to Concurrent Anticonvulsant Therapy for Infants (1-24 Months of Age) With Refractory Partial-Onset Seizures.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Topiramate (Primary)
  • Indications Partial epilepsies
  • Focus Therapeutic Use
  • Sponsors Janssen Research & Development
  • Most Recent Events

    • 20 Jan 2010 Results were published in Neurology.
    • 20 Jan 2010 Primary endpoint 'Seizure frequency' has not been met.
    • 05 Dec 2008 Results were presented at the 2008 Annual Meeting of the American Epilepsy Society.
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