Clinical trial NCT00662818: Telcagepant (MK-0974) Treatment of Migraine in Participants With Stable Vascular Disease (MK-0974-034)
Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active Controlled, Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Heart Disease
Cerebrovascular Accident
TIA (Transient Ischemic Attack)
Vascular Diseases
Peripheral Vascular Diseases
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-04-21
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of telcagepant in the treatment of acute migraine in participants with stable vascular disease. Acetaminophen/paracetamol (APAP) will be used as an active comparator in this study. The primary hypothesis of this study is that telcagepant 300 mg is superior to placebo.


Eligibility criteria: Inclusion Criteria:

* Stable coronary artery disease for 3 months or more
* 18 years of age or older with a history of migraine with or without aura
* Must use acceptable contraception throughout the study

Exclusion Criteria:

* Pregnant, breast-feeding, or planning to become pregnant during this study
* 50 years of age or older when migraines began
* Other pain syndromes that might interfere with study assessments, uncontrolled psychiatric conditions, dementia, or significant neurological disorders (other than migraine)
* History of gastric, or small intestinal surgery, or has a disease that causes malabsorption

Primary outcomes:
measure: Percentage of Participants With Pain Freedom at 2 Hours Post-dose (Period 1, Migraine Attack 1)
timeFrame: 2 hours post-dose (Up to 6 weeks)
measure: Number of Participants Who Experienced an Adverse Event (AE) Within 14 Days Post-dose
timeFrame: Within 14 days of any dose of study medication (Up to 16 weeks)
measure: Number of Participants Discontinuing Study Drug Due to an AE Within 48 Hours Post-dose
timeFrame: Up to 48 hours post-dose (Up to 14 weeks)
Secondary outcomes:
measure: Percentage of Participants With Pain Relief at 2 Hours Post-dose (Period 1, Migraine Attack 1)
timeFrame: 2 hours post-dose (Up to 6 weeks)
measure: Number of Participants With a Confirmed Vascular Event Within 48 Hours Post-dose
timeFrame: Up to 48 hours after the dose of any study medication (Up to 14 weeks)
measure: Percentage of Participants With Absence of Phonophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
timeFrame: 2 hours post-dose (Up to 6 weeks)
measure: Percentage of Participants With Absence of Photophobia at 2 Hours Post-dose (Period 1, Migraine Attack 1)
timeFrame: 2 Hours post-dose (Up to 6 weeks)
measure: Percentage of Participants With Absence of Nausea at 2 Hours Post-dose (Period 1, Migraine Attack 1)
timeFrame: 2 hours post-dose (Up to 6 weeks)
measure: Percentage of Participants With Sustained Pain Freedom (SPF) at 2 to 24 Hours Post-dose
timeFrame: Up to 24 hours post-dose (Up to 14 weeks)
Other outcomes:
Locations:
Study officials:
References:
citation: 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.