MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

Study Overview
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Brief Summary
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A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo. The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.

Official Title
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A Randomized, Triple-Blind, Double-Dummy, Placebo-Controlled, Parallel Groups, Outpatient Study to Examine the Safety and Efficacy of MK0462 10 mg p.o. and MK0462 5 mg p.o. for the Treatment of Acute Migraine and Migraine Recurrence

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: rizatriptan benzoate (MK0462)
* 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: Rizatriptan 10 mg<br> | Drug: rizatriptan benzoate (MK0462)<br>* Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.<br>|
| Experimental: Rizatriptan 5 mg<br> | Drug: rizatriptan benzoate (MK0462)<br>* Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.<br>|
| Placebo Comparator: Placebo<br> | 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 the Initial Dose of Test Drug | Patients reporting pain relief (defined as a reduction of headache severity from grades 2/3 at baseline to 0/1) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain. | 2 hours after initial dose of test drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Free at 2 Hours After the Initial Dose of Test Drug | Patients reporting pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after the initial dose of test drug. Pain severity was subjectively rated by patients on a scale from grade 0 to 3: Grade 0 - No headache, Grade 1 - Mild pain, Grade 2 - Moderate pain, Grade 3 - Severe pain. | 2 hours after initial dose of test drug | 
| No Disability at 2 Hours After the Initial Dose of Test Drug | Patients with no disability at 2 hours after the initial dose of test drug. Functional disability was subjectively rated on a scale from grade 0 to 3: Grade 0 - Normal, Grade 1 - Daily activities mildly impaired, Grade 2 - Daily activities severely impaired, Grade 3 - Unable to carry out daily activities, requires bedrest | 2 hours after initial dose of test drug | 
| Use of Escape Medication at 2 Hours After the Initial Dose of Test Drug |  | 2 hours after initial dose of test drug | 
| Pain Relief 2 Hours After Treatment for Headache Recurrence | Patients reporting pain relief 2 hours after treatment for headache recurrence (defined as the return of headache to grade 2 or 3 within 24 hours of the initial dose in patients who reported pain relief (grades 0 or 1) at 2 hours). | 2 hours after treatment for recurrence |