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.

Phase 1

• Conditions: Acute treatment of Migraine; MedDRA version: 8.1 Level: LLT Classification code 10027599 Term: Migraine

• Registration Number: EUCTR2006-006187-35-FR
• Lead Sponsor: aboratoires Merck Sharp & Dohme - Chibret

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-15
• Study Completion: 2007-12-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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.

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
<br> Main Objective: - To evaluate the efficacy of MK-0974 (300 mg and 150 mg) compared to placebo in the treatment of acute migraine as measured using pain freedom, pain relief, freedom from photophobia, freedom from phonophobia and freedom from nausea.<br> - To evaluate the safety and tolerability of MK-0974 in the treatment of acute migraine<br> ;<br> Secondary Objective: - To evaluate the efficacy of MK-0974 (300 mg and 150 mg) compared to placebo in the treatment of acute migraine as measured using sustained pain freedom and total migraine freedom.<br> - Examine dose response of MK-0974 for pain freedom and pain relief at 2 hours accross all doses studied (50 mg, 150 mg, 300mg)<br> ;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.