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A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Oral MK0974 in the Acute Treatment of Migraine With or Without Aura
The purpose of this study is to investigate the efficacy and safety of MK0974 compared to a placebo for acute migraine.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1703 |
| Start date | 2007-03 |
| Completion | 2007-12 |
Conditions
- Migraine
Interventions
- MK0974 50 mg
- MK0974 150 mg
- MK0974 300 mg
- Comparator: Placebo
Primary outcomes
- Number of Patients Reporting Pain Freedom at 2 Hours Postdose — 2 hours post dose
Pain Freedom was defined as a reduction of a Grade 2 or 3 severity migraine at baseline to a no pain (Grade 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. - Number of Patients Reporting Pain Relief at 2 Hours Post Dose — 2 hours post dose
Reduction of a Grade 2 or 3 severity migraine at baseline to mild or no pain (Grade 1 or 0) at 2 hours post dose. Headache severity was recorded by the patient in a diary. 0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain. - Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose — 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary. - Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose — 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary. - Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose — 2 hours post dose
Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary.