MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

Study Overview
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Brief Summary
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A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.

Official Title
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A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine

Conditions
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Migraine Headache

Intervention / Treatment
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* Drug: rizatriptan benzoate (MK0462)
* Drug: Comparator: sumatriptan
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant had at least a 6-month history of migraine, with or without aura Participant was male, or if female, must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions Participant was judged to be in good health, apart from migraine Exclusion Criteria: Participant was Pregnant or a nursing mother Participant had a history or current evidence of drug or alcohol abuse Participant had a history or clinical evidence of cardiovascular disease Participant had a clinically significant Electrocardiography (ECG) abnormality Participant had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening Participant had received treatment with an investigational device or compound within 30 days of the study Participant typically suffered from less then 1 or more than 8 attacks of migraine per month Participant had difficulty in distinguishing his/her migraine attacks from tension or interval headaches Participant was currently taking monoamine oxidase inhibitors, methysergide or lithium

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 | Drug: rizatriptan benzoate (MK0462)<br>* single dose 5 mg rizatriptan p.o.<br>* Other names: MK0462;|
| Experimental: 2<br>Sumatriptan | Drug: Comparator: sumatriptan<br>* single dose 50 mg sumatriptan p.o.<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Comparator: Placebo<br>* Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally<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 Treatment | Participants 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 treatment | 
| Time to Relief Within 2 Hours After Treatment | Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg). | within 2 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Free at 2 Hours After Treatment | Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain). | 2 hours after treatment | 
| Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities | Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest). | 2 hours after treatment | 
| Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment | Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment. | 2 hours after treatment | 
| Participants Who Used Escape Medication 2 Hours After the Treatment Dose | Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication. | 2 hours after treatment | 
| Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) | Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence | 24 hours |