Adolescent Migraine Clinical Trial
Official title:
Early Intervention, Randomized, Mulitcenter, Placebo-Controlled, 4-Period Crossover, Multi-Attack Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents
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.
There are two primary treatment comparisons for this study: 1) the percentage of subjects'
pain free at 2 hours after treatment with TREXIMET versus placebo across attacks, and 2) the
percentage of subjects who are sustained pain free at 24 hours after treatment with TREXIMET
versus placebo across attacks.
The following alternative hypothesis will be tested to see if there is a difference in the
proportion of subjects who are pain free at 2 hours with TREXIMET versus placebo at all
attacks, OR there is a difference in the proportion of subjects who are sustained pain free
at 24 hours with TREXIMET versus placebo at all attacks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04064814 -
Evaluation of Efficacy and Safety of add-on Alpha-lipoic Acid on Migraine Prophylaxis in Adolescent Population
|
Phase 4 |