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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

933 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-31

Study Completion Date

1996-09-30

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.

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Detailed Description

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Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Rizatriptan

Group Type EXPERIMENTAL

rizatriptan benzoate (MK0462)

Intervention Type DRUG

single dose 5 mg rizatriptan p.o.

2

Sumatriptan

Group Type EXPERIMENTAL

Comparator: sumatriptan

Intervention Type DRUG

single dose 50 mg sumatriptan p.o.

3

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally

Interventions

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rizatriptan benzoate (MK0462)

single dose 5 mg rizatriptan p.o.

Intervention Type DRUG

Comparator: sumatriptan

single dose 50 mg sumatriptan p.o.

Intervention Type DRUG

Comparator: Placebo

Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally

Intervention Type DRUG

Other Intervention Names

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MK0462

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No