Trial record 2 of 2 for:    migraine | Bristol-Myers [Lead]

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01430442
First received: September 7, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Migraine - Acute
Drug: Placebo matching BMS-927711
Drug: BMS-927711
Drug: Sumatriptan
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pain Freedom (from migraine pain) [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]
    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:
  • Total migraine freedom (pain freedom, coupled with no symptoms of phonophobia, photophobia, or nausea) [ Time Frame: At 2 hours post dose ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: During Double-blind treatment phase (approximately 11 weeks) ] [ Designated as safety issue: Yes ]
  • Sustained pain freedom [ Time Frame: from 2 to 24 hours post dose ] [ Designated as safety issue: No ]
  • Sustained pain freedom [ Time Frame: from 2 to 48 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 885
Study Start Date: October 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

Detailed Description:

Intervention Model: Parallel Versus Comparator + Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
St. 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
Clinvest/ A Division Of Banyan Group, Inc.
Springfield, Missouri, United States, 65807
Mercy Health Research
St. Louis, Missouri, United States, 63141
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
Futuresearch Trials Of Neurology
Austin, Texas, United States, 78731
Premier Research Group Limited
Austin, Texas, United States, 78705
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
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01430442     History of Changes
Other Study ID Numbers: CN170-003
Study First Received: September 7, 2011
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014