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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
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: NCT01430442

  Show 41 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
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 November 24, 2014