drugset / Trial / NCT00387881
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study was designed to determine the efficacy and tolerability of TREXIMET (formerly known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.
Timeline
- Start
- 2006-09
- Primary completion
- 2008-02
- Completion
- 2008-02
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Sumatriptan/Naproxen; p <0.001; Percent difference 18 (95% CI 10 to 25); Cochran-Mantel-Haenszel NCT00387881 ↗
registry analysis (superiority or other test); Placebo vs Sumatriptan/Naproxen; p <0.001; Percent difference 15 (95% CI 8 to 22); Cochran-Mantel-Haenszel NCT00387881 ↗
Publications
- Results Silberstein S, Lipton RB, Goldstein J, Aurora SK, White J, Ochs-Ross R, Lener SE, McDonald SA. Evaluation of a New Fixed-dose Single Tablet of Sumatriptan Formulated with RT Technology and Naproxen Sodium (SumaRT/Nap) for the Acute Treatment of Probable Migraine without Aura. Headache 2008: presented at the American Headache Society Meeting, Boston, MA.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naproxen | Small molecule | 500 mg | — |
| Subject | Sumatriptan | Unknown | 85 mg | — |