Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine

Phase 3

Completed

• Conditions: Migraine Headache
• Interventions: Drug: Placebo; Drug: Sumatriptan

• Registration Number: NCT01462812
• Lead Sponsor: Optinose US Inc.

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-10-27
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Results First Submitted: 2015-04-20
• Results First Submitted QC: 2015-04-20
• Last Update Submitted: 2015-04-20
• Results First Posted: 2015-05-06
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

• Men or women, between the ages of 18 to 65 years
• Diagnosis of migraine, with or without aura
• Experiences between 1 and 8 migraine attacks per month for the past 12 months

Exclusion Criteria

• Inability to distinguish other headaches from migraine
• Experiences headache of any kind at a frequency greater than or equal to 15 days per month
• History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment
• Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
• Chronic opioid therapy (>3 consecutive days in the 30 days prior to screening)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	Placebo	-
Sumatriptan	Sumatriptan	-

Primary Outcome Measures

Name	Time	Method
Headache Relief	120 Minutes	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.

Trial Locations

Locations (15)

Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

Headache Wellnes Center; 🇺🇸 Greensboro, North Carolina, United States

MedVadis; 🇺🇸 Watertown, Massachusetts, United States

DENT Neurologic Institute; 🇺🇸 Amherst, New York, United States

Neurology Center of Ohio; 🇺🇸 Toledo, Ohio, United States

PMG Research of Winston Salem, LLC; 🇺🇸 Winston Salem, North Carolina, United States

PMG Research of Raleigh North carolina, LLC; 🇺🇸 Raleigh, North Carolina, United States

Jefferson Headache Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Michigan Head and Pain Institute; 🇺🇸 Ann Arbor, Michigan, United States

California Medical Clinic for Headache; 🇺🇸 Santa Monica, California, United States

ClinVest; 🇺🇸 Springfield, Missouri, United States

Mercy Health Research; 🇺🇸 St. Louis, Missouri, United States

San Francisco Clinical Research Center; 🇺🇸 San Francisco, California, United States

Coastal Carolina Research Center; 🇺🇸 Mt. Pleasant, South Carolina, United States

Associated Neurologists of Southern CT, P.C.; 🇺🇸 Fairfied, Connecticut, United States