Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081)

Study Overview
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Brief Summary
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The purpose of this study is to test the effectiveness of rizatriptan benzoate in the early treatment of an acute migraine attack.

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Factorial Design Clinical Trial to Study the Efficacy and Safety of MK0462 / Rizatriptan 10 mg for the Early Treatment of Acute Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: Comparator: rizatriptan benzoate
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than one year history of migraine Attacks typically mild when they begin and progress to moderate or severe Experience 1-4 migraine attacks per month Exclusion Criteria: More than 15 headache days per month Heart disease Uncontrolled high blood pressure

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: 1<br>Active Drug | Drug: Comparator: rizatriptan benzoate<br>* Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack<br>* Other names: MK0462;|
| Placebo Comparator: 2<br>Matching Pbo Comparator | Drug: Comparator: Placebo<br>* Matching placebo; one dose, treatment of a single migraine attack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Are Pain Free at 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), or 3 (severe). Pain free = rating of 0 (no pain) at 2 hours post-dose. | 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With 24-Hour Sustained Pain Freedom | 24-hour sustained pain freedom (defined as pain freedom from 2 to 24 hours post-dose and no use of rescue medication). Participants assessed pain severity and use of rescue medication on a paper diary. | 24 hours post-dose | 
| Number of Participants With no Rescue Use up to 24 Hours Post-Dose | Participants recorded use of any rescue medication up to 24 hours after dosing with study medication on a paper diary. | 24 hours post-dose | 
| Number of Participants With Absence of Photophobia at 2 Hours Post-dose | Absence or presence of photophobia was recorded by the participants on a paper diary. Absence is defined as no photophobia at 2 hours post-dose. | 2 hours post-dose | 
| Number of Participants With Absence of Phonophobia at 2 Hours Post-dose | Absence or presence of phonophobia was recorded by the participants on a paper diary. Absence is defined as no phonophobia at 2 hours post-dose. | 2 hours post-dose | 
| Number of Participants With Absence of Nausea at 2 Hours Post-dose | Absence or presence of nausea was recorded by the participants on a paper diary. Absence is defined as no nausea at 2 hours post-dose. | 2 hours post-dose | 
| Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose | Level of functional disability was assessed on a paper diary by the participants. Level of functional disability was rated as: normal, mildly impaired, severely impaired or unable to do activities, requires bed rest. Absence of functional disability defined as a rating of normal at 2 hours post-dose. | 2 hours post-dose |