Safety and Efficacy Study of MK0974 in the Acute Migraine (0974-016)

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 MK0974 compared to a placebo for acute migraine.

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: MK0974 50 mg
* Drug: MK0974 150 mg
* Drug: MK0974 300 mg
* Drug: Comparator: Placebo


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 Exclusion Criteria: Patient is pregnant/breast-feeding (or is a female expecting to conceive during the study period) Patient has history or evidence of uncontrolled diabetes, or Human Immunodeficiency Virus (HIV) disease. Patient has uncontrolled cardiovascular 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

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: MK0974 50 mg<br>MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack | Drug: MK0974 50 mg<br> <br> * Other names: MK0974;|
| Experimental: MK0974 150 mg<br>MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack | Drug: MK0974 150 mg<br> <br> * Other names: MK0974;|
| Experimental: MK0974 300 mg<br>MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack | Drug: MK0974 300 mg<br> <br> * Other names: MK0974;|
| Placebo Comparator: Placebo<br>Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack | Drug: Comparator: Placebo<br>* MK0974 50 mg soft gel capsule Placebo; MK0974 150 mg soft gel capsule Placebo; MK0974 300 mg soft gel capsule Placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Reporting Pain Freedom at 2 Hours Postdose | 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. | 2 hours post dose | 
| Number of Patients Reporting Pain Relief at 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. | 2 hours post dose | 
| Number of Patients Reporting Absence of Photophobia at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including photophobia) was recorded by the patient in a diary. | 2 hours post dose | 
| Number of Patients Reporting Absence of Phonophobia at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including phonophobia) was recorded by the patient in a diary. | 2 hours post dose | 
| Number of Patients Reporting Absence of Nausea at 2 Hours Post Dose | Respective experience (yes/no) of migraine-associated symptoms (including nausea) was recorded by the patient in a diary. | 2 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Have Sustained Pain-Freedom From 2 to 24 Hours Postdose | Pain Freedom at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache during the 24 hours after dosing with study medication. | 2 to 24 hours postdose | 
| Number of Patients Who Have Total Migraine Freedom 2 to 24 Hours Postdose | Pain Freedom and no migraine-associated symptoms at 2 hours postdose, with no administration of any rescue medication and no occurrence thereafter of a mild/moderate/severe headache or migraine-associated symptom during the 24 hours after dosing with study medication. | 2 to 24 hours postdose | 
| Number of Patients Who Have Total Migraine Freedom 2 Hours Postdose | Pain Freedom and no migraine-associated symptoms at 2 hours postdose. | 2 hours postdose |