Dose Ranging Study of a Drug for the Treatment of Acute Migraine
This study has been completed.
Sponsor:
Bristol-Myers Squibb
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
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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
Hide Study LocationsLocations
| 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 May 16, 2013