A phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK-0974 in the Acute Treatment of Migraine with or Without Aura. - Study the Safety and Efficacy of MK-0974 in the Acute Migraine

• Conditions: Migraine; MedDRA version: 8.1Level: LLTClassification code 10027599Term: Migraine

• Registration Number: EUCTR2006-006187-35-DE
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

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) yes
F.1.3.1 Number of subjects for this age range

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.

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 in the treatment of acute migraine.;Secondary Objective: ;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.