Conditions: Migraine Disorders
Keywords: Migraine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 902
Healthy volunteers: no

Brief summary:
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.

Detailed description:

Arms:
arm 1: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. arm 2: Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.

Interventions: intervention 1: MAP0004 intervention 2: Placebo
Intervention descriptions: intervention 1: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only. intervention 2: Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.

Protocol document: