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
Overview
- Phase
- Phase 2
- Intervention
- Treximet
- Conditions
- Migraine
- Sponsor
- Premiere Research Institute
- Enrollment
- 104
- Locations
- 4
- Primary Endpoint
- Number of Participants With 2-hour Pain Free Active Study Drug
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects between the ages of 12-
- •Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least 1 but no more than 8 attacks per month on average over the past 6 months prior to screening visit. Attacks should be moderate to severe and last for at least 3 hours.
- •Subject is able to distinguish migraine from other headaches and can determine when a mild headache will become a moderate/severe migraine.
- •Female subjects are eligible for participation provided they are of non-child bearing potential or if started menses; they are on a stable regimen of approved contraception.
- •Subject and subject's parent or legal guardian are able to read and write English.
- •Subject is able to read, comprehend, and complete subject diaries.
- •Subjects' parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.
- •Subject is willing and able to provide Informed Assent prior to entry into the study.
- •Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the study:
Exclusion Criteria
- Not provided
Arms & Interventions
Active, Active, Active, Placebo
One fifth of the 105 subjects will be randomized to this arm and treat their four migraines in this order. First three will be treated with Active Treximet and the last or 4th migraine will be treated with Placebo.
Intervention: Treximet
Active, Active, Active, Placebo
One fifth of the 105 subjects will be randomized to this arm and treat their four migraines in this order. First three will be treated with Active Treximet and the last or 4th migraine will be treated with Placebo.
Intervention: Placebo
Active, Active, Placebo, Active
This is another of the five treatment arms. One fifth of the 105 subjects will be randomized to this group and will treat the first two migraines with Active drug, Treximet, and then the third migraine with placebo and the last (4th) migraine with Treximet.
Intervention: Treximet
Active, Active, Placebo, Active
This is another of the five treatment arms. One fifth of the 105 subjects will be randomized to this group and will treat the first two migraines with Active drug, Treximet, and then the third migraine with placebo and the last (4th) migraine with Treximet.
Intervention: Placebo
Active, Placebo, Active, Active
Approximately one fifth of the 105 subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo. The final two migraines treated will be with Active study drug.
Intervention: Treximet
Active, Placebo, Active, Active
Approximately one fifth of the 105 subjects will be randomized to this group and treat their first migraine with Active Treximet and the second migraines with Placebo. The final two migraines treated will be with Active study drug.
Intervention: Placebo
Placebo, Active, Active, Active
One fifth of the 105 subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet.
Intervention: Treximet
Placebo, Active, Active, Active
One fifth of the 105 subjects will be randomized to this treatment arm, where they will treat the first headache with placebo and the remaining three migraines will be treated with Active treximet.
Intervention: Placebo
Active, Active, Active, Active
One fifth of the subject will treat all their migraines with Active Treximet.
Intervention: Treximet
Outcomes
Primary Outcomes
Number of Participants With 2-hour Pain Free Active Study Drug
Time Frame: 3 years
All data was collected and measured from self-reported patient diaries
Percentage of Migraine Attacks With Sustained Pain Free Response From 2 to 24 Hours Post-Dose
Time Frame: 3 years
All data was collected and measured from self-reported patient diaries
Percentage of Migraine Attacks With Pain Free Response at 2 Hours Post-Dose Following Early Intervention
Time Frame: 3 years
All data was collected and measured from self-reported patient diaries
Secondary Outcomes
- To Evaluate the Consistency of Response Across Four Migraine Attacks at 1, 2, 4, and 24 Hours After Treatment. Frequency of Rescue Medications Needed and the Consistency of Other Symptom Relief i.e. Nausea, Vomiting, Photophobia, and Phonophobia.(3 years)