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

  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

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 17, 2014