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

September 7, 2011
December 4, 2012
October 2011
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01430442 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Dose Ranging Study of a Drug for the Treatment of Acute Migraine
Phase IIb: Double-Blind, Randomized, Placebo Controlled, Dose-ranging Trial of BMS-927711 for the Acute Treatment of Migraine

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.

Intervention Model: Parallel Versus Comparator + Placebo

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Migraine - Acute
  • Drug: Placebo matching BMS-927711
    Capsule, Oral, 0mg, One time, One dose
  • Drug: BMS-927711
    Capsule, Oral, 10mg, One time, One dose
  • Drug: BMS-927711
    Capsule, Oral, 25mg, One time, One dose
  • Drug: BMS-927711
    Capsule, Oral, 75mg, One time, One dose
  • Drug: BMS-927711
    Capsule, Oral, 150mg, One time, One dose
  • Drug: BMS-927711
    Capsule, Oral, 300mg, One time, One dose
  • Drug: BMS-927711
    Capsule, Oral, 600mg, One time, One dose
  • Drug: Sumatriptan
    Capsule, Oral, 100mg, One time, One dose
    Other Name: Imitrex®
  • Placebo Comparator: Arm 1: Placebo matching BMS-927711
    Intervention: Drug: Placebo matching BMS-927711
  • Experimental: Arm 2: BMS-927711 and Placebo matching BMS-927711
    Interventions:
    • Drug: Placebo matching BMS-927711
    • Drug: BMS-927711
  • Experimental: Arm 3: BMS-927711 and Placebo matching BMS-927711
    Interventions:
    • Drug: Placebo matching BMS-927711
    • Drug: BMS-927711
  • Experimental: Arm 4: BMS-927711 and Placebo matching BMS-927711
    Interventions:
    • Drug: Placebo matching BMS-927711
    • Drug: BMS-927711
  • Experimental: Arm 5: BMS-927711 and Placebo matching BMS-927711
    Interventions:
    • Drug: Placebo matching BMS-927711
    • Drug: BMS-927711
  • Experimental: Arm 6: BMS-927711 and Placebo matching BMS-927711
    Interventions:
    • Drug: Placebo matching BMS-927711
    • Drug: BMS-927711
  • Experimental: Arm 7: BMS-927711 and Placebo matching BMS-927711
    Interventions:
    • Drug: Placebo matching BMS-927711
    • Drug: BMS-927711
  • Active Comparator: Arm 8: Sumatriptan and Placebo matching BMS-927711
    Interventions:
    • Drug: Placebo matching BMS-927711
    • Drug: Sumatriptan
Marcus R, Goadsby PJ, Dodick D, Stock D, Manos G, Fischer TZ. BMS-927711 for the acute treatment of migraine: a double-blind, randomized, placebo controlled, dose-ranging trial. Cephalalgia. 2014 Feb;34(2):114-25. doi: 10.1177/0333102413500727. Epub 2013 Aug 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
885
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01430442
CN170-003
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP