An Efficacy and Tolerability Study of Topiramate in Participants With Migraine
Summary
The purpose of this study is to investigate the adequacy (reasonably good) of topiramate therapy (medicine or medical care given to a participant for a disease or condition) in prevention of migraine (type of severe headache that occurs periodically and is often associated with nausea, vomiting, and constipation or diarrhea) by comparing standard titration (slow increase in drug dosage, guided by patient's responses) therapy to slow titration therapy and slow titration therapy boosted by the concurrent use of propranolol in participants with migraine with or without aura (having to do with the ear) for more than or equal to 2 attacks per month.
Timeline
- Start
- 2006-07
- Primary completion
- 2008-07
- Completion
- 2008-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Topiramate Standard vs Topiramate Slow vs Topiramate Slow and Propranolol Booster; p = 0.6207; ANOVA NCT01060111 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Propranolol | Small molecule | 80 mg | — |
| Subject | Topiramate | Small molecule | 50 mg | — |
| Subject | Topiramate | Small molecule | 100 mg | — |