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Dose Ranging Study of a Drug for the Treatment of Acute Migraine

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ClinicalTrials.gov Identifier: NCT01430442
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is the exploration of a wide range of BMS-927711 doses that will reveal at least one dose that is safe and clinically superior to placebo in the treatment of acute migraine.

Condition or disease Intervention/treatment Phase
Migraine - Acute Drug: Placebo matching BMS-927711 Drug: BMS-927711 Drug: Sumatriptan Phase 2

Detailed Description:
Intervention Model: Parallel Versus Comparator + Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 885 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine
Study Start Date : October 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Sumatriptan

Arm Intervention/treatment
Placebo Comparator: Arm 1: Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Experimental: Arm 2: BMS-927711 and Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Drug: BMS-927711
Capsule, Oral, 10mg, One time, One dose

Experimental: Arm 3: BMS-927711 and Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Drug: BMS-927711
Capsule, Oral, 25mg, One time, One dose

Experimental: Arm 4: BMS-927711 and Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Drug: BMS-927711
Capsule, Oral, 75mg, One time, One dose

Experimental: Arm 5: BMS-927711 and Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Drug: BMS-927711
Capsule, Oral, 150mg, One time, One dose

Experimental: Arm 6: BMS-927711 and Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Drug: BMS-927711
Capsule, Oral, 300mg, One time, One dose

Experimental: Arm 7: BMS-927711 and Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Drug: BMS-927711
Capsule, Oral, 600mg, One time, One dose

Active Comparator: Arm 8: Sumatriptan and Placebo matching BMS-927711 Drug: Placebo matching BMS-927711
Capsule, Oral, 0mg, One time, One dose

Drug: Sumatriptan
Capsule, Oral, 100mg, One time, One dose
Other Name: Imitrex®




Primary Outcome Measures :
  1. Pain Freedom (from migraine pain) [ Time Frame: 2 hours post-dose ]
    This variable will be set to "yes" if headache pain intensity level is reported as "no pain" on the four point intensity scale.


Secondary Outcome Measures :
  1. Total migraine freedom (pain freedom, coupled with no symptoms of phonophobia, photophobia, or nausea) [ Time Frame: At 2 hours post dose ]
  2. Frequency and severity of adverse events [ Time Frame: During Double-blind treatment phase (approximately 11 weeks) ]
  3. Sustained pain freedom [ Time Frame: from 2 to 24 hours post dose ]
  4. Sustained pain freedom [ Time Frame: from 2 to 48 hours post dose ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patient with at least 1 year history of migraines (with or without aura) including the following;

    • Migraine attacks more than 1 year with age onset prior to 50 years of age;
    • Migraine attacks, on average, last about 4 - 72 hours if untreated;
    • No more than 8 attacks of moderate to severe intensity per month within last 3 months;
    • Patient must be able to distinguish migraine attacks from tension/cluster attacks and must have consistent migraine headaches of at least 2 migraine headaches attacks of severe to moderate intensity in each of the last 3 months;
    • Less than 15 days of headache (migraine or non migraine) per month in each of 3 months prior to screening;
  • Male and female ≥ 18 years and ≤ age 65
  • No clinically significant abnormality identified on the medical or laboratory evaluation

Exclusion Criteria:

  • Patient has a history of basilar migraine or hemiplegic migraine
  • Patient does not receive migraine relief from triptan migraine treatment
  • Medications that may alter the pH of the stomach (acid reducing agents), such as H-2 antagonists, Proton Pump inhibitors (PPI), antacids
  • History of ergotamine or triptan intake greater than/equal 10 days per month on a regular basis for greater than 3 months
  • History of non-narcotic analgesic intake on greater then/equal 15 days per month for greater than/equal 3 months

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): NCT01430442


  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Clinical Res. Advantage Inc/ Desert Clinical Research Llc
Tempe, Arizona, United States, 85282
United States, California
University Of California, San Francisco
San Francisco, California, United States, 94115
California Medical Clinic For Headache
Santa Monica, California, United States, 90404
Encompass Clinical Research
Spring Valley, California, United States, 91978
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Colorado
Radiant Research, Inc.
Denver, Colorado, United States, 80239
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
Renstar Medical Research
Ocala, Florida, United States, 34471
Compass Research, Llc
Orlando, Florida, United States, 32806
Broward Research Group
Pembroke Pines, Florida, United States, 33026
Comprehensive Clinical Development, Inc
Saint Petersburg, Florida, United States, 33716
United States, Illinois
Diamond Headache Clinic, Ltd.
Chicago, Illinois, United States, 60642
United States, Massachusetts
Milford Emergency Associates, Inc.
Milford, Massachusetts, United States, 01757
Medvadis Research Corporation
Watertown, Massachusetts, United States, 02472
United States, Michigan
Michigan Head Pain And Neurological Institute
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States, 55402
United States, Missouri
The Center For Pharmaceutical Research. Pc
Kansas City, Missouri, United States, 64114
Mercy Health Research
Saint Louis, Missouri, United States, 63141
Clinvest/ A Division Of Banyan Group, Inc.
Springfield, Missouri, United States, 65807
United States, New York
Regional Clinical Research Inc.
Endwell, New York, United States, 13760
Central New York Clinical Research
Manlius, New York, United States, 13104
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, North Carolina
Pharmquest
Greensboro, North Carolina, United States, 27408
Wake Research Associates
Raleigh, North Carolina, United States, 27612
Pmg Research Of Winston-Salem
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Community Research
Cincinnati, Ohio, United States, 45227
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Clinical Research Of Philadelphia, Llc
Philadelphia, Pennsylvania, United States, 19114
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Coastal Carolina Research Center, Inc.
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Clinsearch, Llc
Chattanooga, Tennessee, United States, 37421
United States, Texas
Premier Research Group Limited
Austin, Texas, United States, 78705
Futuresearch Trials Of Neurology
Austin, Texas, United States, 78731
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
United States, Utah
J. Lewis Research, Inc
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc
Salt Lake City, Utah, United States, 84121
United States, Virginia
The Innovative Clinical Research Center
Alexandria, Virginia, United States, 22304
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23454
United States, Washington
Swedish Pain And Headache Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01430442     History of Changes
Other Study ID Numbers: CN170-003
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

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