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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1473 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-03-31

Study Completion Date

1996-07-31

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.

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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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Rizatriptan 10 mg

Group Type EXPERIMENTAL

rizatriptan benzoate (MK0462)

Intervention Type DRUG

Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.

Rizatriptan 5 mg

Group Type EXPERIMENTAL

rizatriptan benzoate (MK0462)

Intervention Type DRUG

Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type DRUG

Placebo to rizatriptan

Interventions

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rizatriptan benzoate (MK0462)

Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache.

Intervention Type DRUG

Comparator: placebo

Placebo to rizatriptan

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No