A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine
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
Outcome
Missed primary endpoint
registry Topiramate 100 mg vs Placebo; p = 0.1646; Least Square (LS) mean difference -0.4 (95% CI -1.0 to 0.2) NCT01081795 ↗
registry Topiramate (JNS019) 50 mg vs Placebo; p = 0.4479; LS mean difference -0.2 (95% CI -0.8 to 0.4) NCT01081795 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Topiramate | Small molecule | 50 mg | Oral |
| Subject | Topiramate | Small molecule | 100 mg | Oral |