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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01462812
Recruitment Status : Completed
First Posted : October 31, 2011
Results First Posted : May 6, 2015
Last Update Posted : May 6, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Migraine Headache Drug: Sumatriptan Drug: Placebo Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
Drug Information available for: Sumatriptan
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Sumatriptan Drug: Sumatriptan
Sumatriptan 20mg
Placebo Comparator: Matching placebo Drug: Placebo
Matching placebo


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462812


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01462812     History of Changes
Other Study ID Numbers: OPN-SUM-MIG-3301
First Posted: October 31, 2011    Key Record Dates
Results First Posted: May 6, 2015
Last Update Posted: May 6, 2015
Last Verified: August 2012

Keywords provided by Optinose US Inc.:
Migraine
Headache
Sumatriptan

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Sumatriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs