Migraine MedDRA version: 8.1 Level: LLT Classification code 10027599 Term: Migraine
Conditions
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient has at least 1 year history of migraine (with or without aura). Females of child bearing potential must use acceptable contraception throughout trial. Patient is in general good health based on 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is pregnant/breast-feeding (or is a female expecting to conceive during study period). Patient has uncontrolled hypertension (high blood pressure), uncontrolled diabetes, HIV disease, or other significant disease. Patient has major depression, other pain syndromes that might interfere with study assessments, 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. Patient has history or presence of a significant cardiovascular disorder (e.g. acute coronary syndrome [e.g. MI or unstable angina]; coronary artery intervention [e.g. CABG or PTCA]; congestive heart failure or arrhythmia. Note: Patients with evidence of an MI on ECG will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of MK-0974 compared to placebo and zolmitriptan in the treatment of acute migraine.;Secondary Objective: To evaluate the efficacy and safety of MK-0974 compared to placebo and zolmitriptan in the treatment of acute migraine.;Primary end point(s): 1) headache freedom (to Grade 0); 2) freedom from photophobia; 3) freedom from phonophobia, 4) freedom from nausea and 5) headache relief (to Grade 0 or 1), respectively, at 2 hours post treatment. | — |
Countries
Denmark, Italy, Netherlands, United Kingdom
Outcome results
None listed