Treatment of Migraine in Patients With Stable Vascular Disease (0974-034)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00662818
First received: April 17, 2008
Last updated: November 18, 2013
Last verified: November 2013

April 17, 2008
November 18, 2013
March 2008
September 2009   (final data collection date for primary outcome measure)
To evaluate the efficacy of MK0974 compared to placebo in the treatment of acute migraine in patients with stable vascular disease, as measured by pain freedom at 2 hours post dose. [ Time Frame: 2 hours post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662818 on ClinicalTrials.gov Archive Site
Number of confirmed vascular event within 48 hours after any dose of study medication. [ Time Frame: following 12 weeks of treatment ] [ Designated as safety issue: Yes ]
To evaluate the safety and tolerability of MK0974 compared to acetaminophen/paracetamol in the treatment of acute migraine in patients with stable vascular disease following 12 weeks of treatment. [ Time Frame: following 12 weeks of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Treatment of Migraine in Patients With Stable Vascular Disease (0974-034)
A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease

The purpose of this study is to evaluate the safety and efficacy of MK0974 in the treatment of acute migraine in patients with stable vascular disease.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Migraine Disorders
  • Heart Disease
  • Cerebrovascular Accident
  • TIA (Transient Ischemic Attack)
  • Vascular Diseases
  • Peripheral Vascular Diseases
  • Drug: Comparator: MK0974
    MK0974 (300 mg soft gel capsules or 280 mg tablets)
  • Drug: Comparator: acetaminophen
    acetaminophen (500 mg X 2 dosage units)
  • Drug: Comparator: Placebo
    placebo (0 mg soft gel capsules)
  • Active Comparator: 1
    Crossover study: All migraine attacks to be treated with up to 12 doses of MK0974 over the 1st six week treatment period. This will be followed by up to 12 doses of acetaminophen/paracetamol (1000 mg dry filled capsules) over the 2nd six week treatment period.
    Interventions:
    • Drug: Comparator: MK0974
    • Drug: Comparator: acetaminophen
  • Active Comparator: 2
    Crossover study: All migraine attacks to be treated with one dose of placebo and up to 11 doses of acetaminophen over the 1st six week treatment period. This will be followed by up to 12 doses of MK0974 over the 2nd six week treatment period.
    Interventions:
    • Drug: Comparator: MK0974
    • Drug: Comparator: acetaminophen
    • Drug: Comparator: Placebo
Ho TW, Ho AP, Chaitman BR, Johnson C, Mathew NT, Kost J, Fan X, Aurora SK, Brandes JL, Fei K, Beebe L, Lines C, Krucoff MW. Randomized, controlled study of telcagepant in patients with migraine and coronary artery disease. Headache. 2012 Feb;52(2):224-35. doi: 10.1111/j.1526-4610.2011.02052.x. Epub 2012 Jan 6. PubMed PMID: 22221076.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has stable coronary artery disease for 3 months or more
  • Patient is 18 years of age or older with a history of migraine with or without aura
  • Patients must use acceptable contraception throughout the study

Exclusion Criteria:

  • Patient is pregnant, breast-feeding, or planning to become pregnant during this study
  • Patient was 50 years of age or older when migraines began
  • Patient has other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
  • Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00662818
0974-034, MK0974-034, 2007_545
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

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