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Phase III Double Blind Randomized Placebo Controlled Trial Using 20% Intra-Oral Ketoprofen Gel for Migraine Prevention.
Intra-Oral Topical Ketoprofen gel, applied to a branch of the trigeminal nerve, has been shown to prevent migraines when used once daily for 3 months in open label studies. This is a randomized, double-blind, placebo controlled phase III prevention trial to determine safety and efficacy.
Details
| Lead sponsor | Behar, Caren, M.D. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 67 |
| Start date | 2009-10 |
| Completion | 2011-06 |
Conditions
- Migraine
Interventions
- topical intraoral ketoprofen gel
- Placebo Gel
Primary outcomes
- Change in number of migraine days per month — 3 months
Number of migraine days per month will be compared before gel use and at the end of 3 months of use.
Countries
United States