A Multicenter, Randomized, Double-Blind, Active- and Placebo-Controlled, Period Crossover Study to Evaluate the Safety and Efficacy of MK-0974 in the Treatment of Acute Migraine in Patients With Stable Vascular Disease

Conditions: migraine, coronary artery disease
MedDRA version: 9.1Level: LLTClassification code 10027599Term: Migraine
MedDRA version: 9.1Level: LLTClassification code 10011078Term: Coronary artery disease

Registration Number: EUCTR2007-007723-40-AT

Lead Sponsor: Merck Sharp & Dohme GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

•Patient has a history of migraine headache with or without aura greater than 1 year.
•Patient has a clinical diagnosis of stable coronary artery disease (CAD) for greater than or equal to 3 months prior to Visit 1 (screening).
•Women and men of childbearing potential must use acceptable contraception throughout the trial.
•Patient is judged to be in satisfactory health based on the screening assessment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patient is pregnant, or breast-feeding, or is a female expecting to conceive within the projected duration of the study.
•Patient’s ECG is difficult to interpret.
•Patient has, within 3 months of screening a class III or IV congestive heart failure, ejection fraction <40%, unstable angina, MI, TIA, any coronary or non-coronary revascularization procedure.
•Patient has uncontrolled hypertension (high blood pressure), uncontrolled diabetes, HIV disease, or other significant disease, atrial fibrillation, clinically significant ventricular arrhythmia or any implanted electrical device.
•Patient exhibits bradycardia or heart rate extremes that preclude the patient’s safety.
•Patient has a history of predominantly mild headache attacks or migraine headaches that usually resolve spontaneously without treatment in less than 2 hours.
•Patient has confounding pain syndromes, 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.
•Patient has a history of cancer within the last 5 years.