Treatment of Multiple Attacks of Acute Migraine (0462-025)

Study Overview
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Brief Summary
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A study to evaluate rizatriptan for the treatment of multiple attacks of acute migraine compared to placebo.

Official Title
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A Randomized, Triple-Blind, Placebo-Controlled, Outpatient Study to Examine the Safety and Efficacy of MK462 10 mg p.o. in the Treatment of Multiple Attacks of Migraine Headache

Conditions
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Migraine Headache

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient had at least a 6-month history of migraine, with or without aura Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions. Patient was judged to be in good health, apart from migraine Exclusion Criteria: Patient was pregnant or a nursing mother. Patient had abused drugs or alcohol within 12 months prior to entering the study Patient had a history of cardiovascular disease Patient had clinically significant ECG abnormality Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening Patient received treatment with an investigational device or compound within 30 days of the study start Patient typically suffered from less then 1 or more than 8 attacks of migraine per month Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches Patient had prior exposure to rizatriptan

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Treatment Sequence 1<br>Placebo-Rizatriptan-Rizatriptan-Rizatriptan | Drug: rizatriptan benzoate<br>* Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache<br>* Other names: MK0462;Drug: Comparator: Placebo<br>* Placebo to Rizatriptan, Oral Tablet<br>|
| Experimental: Treatment Sequence 2<br>Rizatriptan-Placebo-Rizatriptan-Rizatriptan | Drug: rizatriptan benzoate<br>* Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache<br>* Other names: MK0462;Drug: Comparator: Placebo<br>* Placebo to Rizatriptan, Oral Tablet<br>|
| Experimental: Treatment Sequence 3<br>Rizatriptan-Rizatriptan-Placebo-Rizatriptan | Drug: rizatriptan benzoate<br>* Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache<br>* Other names: MK0462;Drug: Comparator: Placebo<br>* Placebo to Rizatriptan, Oral Tablet<br>|
| Experimental: Treatment Sequence 4<br>Rizatriptan-Rizatriptan-Rizatriptan-Placebo | Drug: rizatriptan benzoate<br>* Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache<br>* Other names: MK0462;Drug: Comparator: Placebo<br>* Placebo to Rizatriptan, Oral Tablet<br>|
| Experimental: Treatment Sequence 5<br>Rizatriptan-Rizatriptan-Rizatriptan-Rizatriptan | Drug: rizatriptan benzoate<br>* Rizatriptan 10 mg p.o. at onset of moderate to severe migraine headache<br>* Other names: MK0462;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief at 2 Hours During the First Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) at baseline to grades 0 or 1 (no headache or mild) at 2 hours after initial dosing for the first migraine attack | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief at 2 Hours During the Second Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the second migraine attack | 2 hours | 
| Pain Relief at 2 Hours During the Third Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the third migraine attack | 2 hours | 
| Pain Relief at 2 Hours During the Fourth Migraine Attack Period | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe) to grades 0 or 1 (no headache or mild) at 2 hours after dosing for the fourth migraine attack | 2 hours |