Conditions: Migraine Headache Aura
Keywords: Migraine, Staccato Prochlorperazine Migraine headache with or without aura.
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 400
Healthy volunteers: no

Brief summary:
Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine headaches. In October 2005, we completed a 75 patient, multi-center, double-blind placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been initiated to assess the efficacy and safety in outpatients with migraine headache with or without aura.

Detailed description:

Arms:
arm 1: Inhaled Staccato Placebo arm 2: Inhaled Staccato Prochlorperazine 5 mg arm 3: Inhaled Staccato Prochlorperazine 7.5 mg arm 4: Inhaled Staccato Prochlorperazine 10 mg

Interventions: intervention 1: Inhaled Placebo intervention 2: Inhaled PCZ 5 mg intervention 3: Inhaled PCZ 7.5 mg intervention 4: Inhaled PCZ 10 mg
Intervention descriptions: intervention 1: Inhaled Staccato Placebo intervention 2: Inhaled Staccato Prochlorperazine 5 mg intervention 3: Inhaled Staccato Prochlorperazine 7.5 mg intervention 4: Inhaled Staccato Prochlorperazine 10 mg

Protocol document: