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

Migraine Headache Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of a Single 20 mg Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine With or Without Aura

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462812
• Other study ID #: OPN-SUM-MIG-3301
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2011
• Last updated: April 20, 2015
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2012
• Source: Optinose US Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Migraine Disorders
• Migraine Headache

Intervention

Drug:
• Sumatriptan
Sumatriptan 20mg
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	DENT Neurologic Institute	Amherst	New York
United States	Michigan Head and Pain Institute	Ann Arbor	Michigan
United States	Associated Neurologists of Southern CT, P.C.	Fairfied	Connecticut
United States	Headache Wellnes Center	Greensboro	North Carolina
United States	Coastal Carolina Research Center	Mt. Pleasant	South Carolina
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	PMG Research of Raleigh North carolina, LLC	Raleigh	North Carolina
United States	San Francisco Clinical Research Center	San Francisco	California
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	Neurology Center of Ohio	Toledo	Ohio
United States	MedVadis	Watertown	Massachusetts
United States	Premiere Research Institute	West Palm Beach	Florida
United States	PMG Research of Winston Salem, LLC	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Optinose US Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Relief	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.	120 Minutes	No