drugset / Trial / NCT00387881

TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)

NCT00387881

Phase 3 Completed 679 enrolled GlaxoSmithKline
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

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

EvaluationDrugModalityDoseRoute
Subject Naproxen Small molecule 500 mg
Subject Sumatriptan Unknown 85 mg

Indications