Conditions: Migraine Headache
Keywords: Migraine Headache Sumatriptan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 223
Healthy volunteers: no

Brief summary:
The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.

Detailed description:
The primary objective for this study is to compare headache relief (defined as a reduction from moderate \[Grade 2\] or severe \[Grade 3\] pain to none \[Grade 0\] or mild \[Grade 1\] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sumatriptan intervention 2: Placebo
Intervention descriptions: intervention 1: Sumatriptan 20mg intervention 2: Matching placebo

Protocol document: