A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 420
- Primary Endpoint
- Pain Relief at 2 Hours
Study Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient has at least 1 year history of migraine (with or without aura)
- •Females of childbearing years must use acceptable contraception throughout trial
- •Patient is in general good health based on screening assessment
Exclusion Criteria
- •Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period)
- •Patient has heart disease, uncontrolled hypertension (high blood pressure), uncontrolled diabetes 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 then 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
Arms & Interventions
MK0974 25 mg
MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: MK0974 (Drug)
MK0974 50 mg
MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: MK0974 (Drug)
MK0974 100 mg
MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: MK0974 (Drug)
MK0974 600 mg
MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: MK0974 (Drug)
MK0974 200 mg
MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: MK0974 (Drug)
MK0974 300 mg
MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: MK0974 (Drug)
MK0974 400 mg
MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: MK0974 (Drug)
Rizatriptan 10 mg
Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
Intervention: Rizatriptan (Drug)
Outcomes
Primary Outcomes
Pain Relief at 2 Hours
Time Frame: 2 hours post dose
Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Pain Relief is defined as participants reporting relief from moderate to severe migraine headache (Grade 2 or 3) to mild or none (Grade 1 or 0) in the setting of a typical migraine attack.
Secondary Outcomes
- Sustained Pain Relief(2-24 hours post dose)
- Pain Freedom at 2 Hours(2 hours post dose)
- Sustained Pain Freedom(2-24 hours post dose)