Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072)

Organon and Co393 enrolled

Overview

The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

393

Conditions

Migraine

Interventions

MK0462, rizatriptan benzoate / Duration of Treatment -1dayDRUG

Comparator: placebo / Duration of Treatment - 1 dayDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patient at least 18 years old * Patient has menses approximately monthly * Patient has at least a 6 month history of migraine and at least a 6 month history of menstrual migraine Exclusion Criteria: * Pregnant and/or nursing mother * Cardiovascular disease * Uncontrolled hypertension

Outcomes

Primary Outcomes

Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary

Secondary Outcomes

Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose recorded in patient diary

Data from ClinicalTrials.gov

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