NCT01667679

Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura

A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Cross-Over Study Evaluating the Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 275 (actual)
• Sponsor: Avanir Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Migraine
• Headaches

Interventions

Type	Name	Description
DRUG	100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally
DRUG	OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2012-08-17
• Last updated: 2017-04-12
• Results posted: 2017-03-14

Locations

13 sites across 1 country: United States