Conditions: Migraine Disorders
Keywords: Migraine with or without aura Migraine efficacy Migraine Migraine headache Adolescent migraine TREXIMET Sumatriptan succinate Naproxen sodium Migraine, acute
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 589
Healthy volunteers: no

Brief summary:
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Detailed description:
The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a \~25 week period.

Arms:
arm 1: Sumatriptan succinate and naproxen sodium combination 10mg/60mg arm 2: Sumatriptan succinate and naproxen sodium combination 30mg/180mg arm 3: Sumatriptan succinate and naproxen sodium combination 85mg/500mg arm 4: Placebo to match

Interventions: intervention 1: Sumatriptan and Naproxen Sodium intervention 2: Placebo
Intervention descriptions: intervention 1: Sumatriptan succinate and naproxen sodium intervention 2: Placebo to match

Protocol document: