A Dose-Finding Study of MK0974 in Acute Migraine (MK0974-004)

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Placebo and Active-Controlled, Dose-Finding Study of MK0974 in the Treatment of Acute Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: Comparator: Placebo
* Drug: MK0974
* Drug: MK0974
* Drug: MK0974
* Drug: MK0974
* Drug: MK0974
* Drug: MK0974
* Drug: MK0974
* Drug: Rizatriptan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. | Drug: Comparator: Placebo<br>* Placebo to match assigned treatment arm; one orally-administered dose<br>|
| Experimental: MK0974 25 mg<br>MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: MK0974<br>* MK0974 25 mg; one orally-administered dose<br>|
| Experimental: MK0974 50 mg<br>MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: MK0974<br>* MK0974 50 mg; one orally-administered dose<br>|
| Experimental: MK0974 100 mg<br>MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: MK0974<br>* MK0974 100 mg; one orally-administered dose<br>|
| Experimental: MK0974 200 mg<br>MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: MK0974<br>* MK0974 200 mg; one orally-administered dose<br>|
| Experimental: MK0974 300 mg<br>MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: MK0974<br>* MK0974 300 mg; one orally-administered dose<br>|
| Experimental: MK0974 400 mg<br>MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: MK0974<br>* MK0974 400 mg; one orally-administered dose<br>|
| Experimental: MK0974 600 mg<br>MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: MK0974<br>* MK0974 600 mg; one orally-administered dose<br>|
| Active Comparator: Rizatriptan 10 mg<br>Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache. | Drug: Rizatriptan<br>* Rizatriptan 10 mg; one orally-administered dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief at 2 Hours | 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. | 2 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Freedom at 2 Hours | 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 freedom is defined as no pain (Grade 0) at 2 hours post dose. | 2 hours post dose | 
| Sustained Pain Relief | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain relief is defined as pain relief at 2 hours and no headache recurrence, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. | 2-24 hours post dose | 
| Sustained Pain Freedom | Pain severity was rated by the participants in a paper diary. Pain severity rating scale: 0 (no pain), 1 (mild), 2 (moderate), 3 (severe). Sustained pain freedom is defined as pain freedom at 2 hours and no headache return to mild/moderate/severe, no need for the optional 2nd dose, or any rescue medication, between 2 and 24 hours post dose. | 2-24 hours post dose |