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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2021

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At a glance

  • Drugs Topiramate (Primary)
  • Indications Partial epilepsies
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen Research & Development; Janssen-Cilag

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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