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

April 20, 2015 updated by: Optinose US Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

223

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
      • Santa Monica, California, United States, 90404
        • California Medical Clinic for Headache
    • Connecticut
      • Fairfied, Connecticut, United States, 06824
        • Associated Neurologists of Southern CT, P.C.
    • Florida
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Medvadis
    • Michigan
      • Ann Arbor, Michigan, United States, 48104-5199
        • Michigan Head and Pain Institute
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest
      • St. Louis, Missouri, United States, 63141
        • Mercy Health Research
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Headache Wellnes Center
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh North carolina, LLC
      • Winston Salem, North Carolina, United States, 27103
        • PMG Research of Winston Salem, LLC
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Neurology Center Of Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Headache Center
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Matching placebo
Drug: Placebo
Matching placebo
Active Comparator: Sumatriptan
Drug: Sumatriptan
Sumatriptan 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Relief
Time Frame: 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.
120 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optinose US Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 31, 2011

Study Record Updates

Last Update Posted (Estimate)

May 6, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPN-SUM-MIG-3301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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