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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 — COMPASS  

Migraine Clinical Trial

Official title:
A Randomized, Double-Blind, Double-Dummy, Active-Controlled, Cross-Over Study A Phase III Study Evaluating the Efficacy and Safety of 20 mg SuMatriptan Powder Delivered IntrAnasally With the Bi-directional Device Compared With 100 mg Sumatriptan TabletsS in Adults With Acute Migraine With or Without Aura

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01667679
Study type Interventional
Source Optinose US Inc.
Contact
Status Completed
Phase Phase 3
Start date August 2012
Completion date June 2014
View Details
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