Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate Efficacy & Safety of ComboProduct Containing Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine in Adolescents
Abstract
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.
Conditions: Migraine.
Primary outcome: Number of Participants With 2-hour Pain Free Active Study Drug; Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose; Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention.
Enrollment: 104 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 104 participants or records.
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