A Multicenter, Double-Blind, Placebo and Active-Controlled, Parallel Group Study to Compare the Efficacy and Safety of Oral MK-0974 With Placebo and Zolmitriptan for the Acute Treatment of Migraine With or Without Aura - MK-0974 Pivotal Study 1 - worldwide (with active comparator)
- Conditions
- MigraineMedDRA version: 14.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
- Registration Number
- EUCTR2006-004257-14-GB
- Lead Sponsor
- Merck Sharp & Dohme Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1800
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method