migraine, coronary artery disease MedDRA version: 9.1 Level: LLT Classification code 10027599 Term: Migraine MedDRA version: 9.1 Level: LLT Classification code 10011078 Term: Coronary artery disease
Conditions
Interventions
Product Code: MK-0974
Pharmaceutical Form: Tablet
Current Sponsor code: MK-974
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 280-
Pharmaceutical form of the place
Sponsors
Merck Sharp & Dohme (Europe) Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of MK-0974 compared to placebo in the treatment of acute migraine in patients with stable vascular disease, as measured by pain freedom at 2 hours postdose.;Secondary Objective: To evaluate the safety and tolerability of MK-0974 compared to acetaminophen/paracetamol in the treatment of acute migraine in patients with stable vascular disease;Primary end point(s): The primary efficacy endpoint is pain freedom at 2 hours postdose to treat the first attack in the first period, with pain freedom defined in this study as a reduction in migraine headache severity to Grade 0. Primary safety endpoints include the proportions of patients with the following clinical adverse experiences: (1) serious, (2) drug related, (3) serious and drug related, (4) discontinued due to an adverse experience, (5) the proportion of patients who have at least one of the following AEs - an ALT and/or AST greater than or equal to 3 times the upper limit of normal. | — |
Countries
Austria, Belgium, Italy
Outcome results
None listed