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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optinose US Inc.
ClinicalTrials.gov Identifier:
NCT01462812
First received: October 27, 2011
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Migraine Headache
Drug: Sumatriptan
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Optinose US Inc.:

Primary Outcome Measures:
  • Headache relief [ Time Frame: 120 Minutes ] [ Designated as safety issue: No ]
    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.


Enrollment: 230
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sumatriptan Drug: Sumatriptan
Sumatriptan 20mg
Placebo Comparator: Matching placebo Drug: Placebo
Matching placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Optinose US Inc.
ClinicalTrials.gov Identifier: NCT01462812     History of Changes
Other Study ID Numbers: OPN-SUM-MIG-3301
Study First Received: October 27, 2011
Last Updated: August 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Optinose US Inc.:
Migraine
Headache
Sumatriptan

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

ClinicalTrials.gov processed this record on October 23, 2014