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Treximet Early Intervention Adolescent Migraine

NCT01016678 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2016-05-04

Study results available
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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.

Conditions

Interventions

DRUG

Treximet

85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.

DRUG

Placebo

Dummy pill comparator

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Premiere Research Institute

    lead OTHER

Principal Investigators

  • Paul K Winner, DO · Premiere Research Institute

  • Andrew Hershey, MD · Cincinnati Childrens Hospital

  • Steve L Linder, MD · Dallas Pediatric Neurology Associates

  • Donald W Lewis, MD · Childrens Hospital of the King's Daughters

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01016678 on ClinicalTrials.gov