Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

Study Overview
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Brief Summary
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A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

Official Title
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A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: rizatriptan benzoate
* Drug: rizatriptan benzoate
* Drug: Comparator: sumatriptan
* 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 Electrocardiography (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 hypersensitivity to sumatriptan Patient had participated in any previous study involving 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: 1<br>rizatriptan 5 mg | Drug: rizatriptan benzoate<br>* single dose administration of 5mg rizatriptan (by Mouth) p.o.<br>* Other names: MK0462;|
| Experimental: 2<br>rizatriptan 10 mg | Drug: rizatriptan benzoate<br>* single dose administration of 10 mg rizatriptan p.o.<br>* Other names: MK0462;|
| Active Comparator: 3<br>sumatriptan 100 mg | Drug: Comparator: sumatriptan<br>* single dose administration of sumatriptan 100 p.o.<br>* Other names: sumatriptan;|
| Placebo Comparator: 4<br>placebo | Drug: Comparator: Placebo<br>* placebo to rizatriptan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief at 2 Hours After Dose | Patients reporting pain relief defined as a reduction of headache severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment | 2 hours after dose | 
| Time to Relief Within 2 Hours After Dose | Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose | within 2 hours after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Free at 2 Hours After Dose | Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain). | 2 hours after dose | 
| Functional Status at 2 Hours After Dose | Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest). | 2 hours after dose | 
| Nausea at 2 Hours After Dose | Patients who recorded the presence or absence of nausea 2 hours after dose | 2 hours after dose |