Study Phase 3

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 Information

Generic NameTopiramateProduct NameTOPAMAX®Therapeutic AreaNervous SystemProduct ClassAntiepilepticsPharmacological SubgroupAntiepilepticsChemical SubgroupOther AntiepilepticsCondition StudiedPartial Seizure Disorder
Sponsor Protocol NumberTOPMATPEP3001Enrollment118Data PartnerJohnson & Johnson% Female48%Mean/Median Age (Years)1% White61%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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