Conditions: Migraine Headaches
Keywords: Migraine Headaches Sumatriptan
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 275
Healthy volunteers: no

Brief summary:
This study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN DEVICE can reduce the pain associated with migraine headaches in 30 minutes after use.

Detailed description:
The primary objective for this study is to compare the proportion of attacks in which pain reduction (defined as a decrease in pain intensity of at least 1 point) is achieved at 30 minutes following 20 mg OPTINOSE SUMATRIPTAN treatment with 100 mg Sumatriptan Tablets

Arms:
arm 1: 20 mg OPTINOSE SUMATRIPTAN Powder Delivered Intranasally With the Bi-directional Device nasally and Placebo Tablet arm 2: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally

Interventions: intervention 1: 100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally intervention 2: OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: