Treximet Early Intervention Adolescent Migraine
Summary
The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4 sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month period. They will be required to have three office visits during the six months. All subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that Treximet will prove to be a safe and effective treatment for this population, that has so few treatment for migraine. And Treximet will be superior over placebo for pain free endpoints at 2 and 24 hours.
Timeline
- Start
- 2010-03
- Primary completion
- 2014-06
- Completion
- 2014-07
Outcome
Mixed primary results
registry p = 0.0038; Difference in percentages 18; Chi-squared NCT01016678 ↗
registry NUMBER Migraine Attack 1: Pain Free at 2 hours post dose for Active Treatmen: 35 Participants NCT01016678 ↗
registry NUMBER Migraine Attack 1: Pain Free at 2 Hours Post Dose for Placebo: 2 Participants NCT01016678 ↗
registry Active Drug vs Placebo; p = 0.1294; difference in percentages 8; Chi-squared NCT01016678 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naproxen | Small molecule | 500 mg | — |
| Subject | Sumatriptan | Unknown | 85 mg | — |