drugset / Trial / NCT01081795

A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine

NCT01081795

Phase 2 Completed 387 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine a recommended dose of topiramate in participants with migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea), to verify the superiority (statistically more effective) of the drug to placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), and to assess if a same therapeutic effect can be observed between this study and overseas Caucasian clinical studies.

Timeline

Start
2007-04
Primary completion
2009-01
Completion
2009-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Topiramate Small molecule 50 mg Oral
Subject Topiramate Small molecule 100 mg Oral

Indications