Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071)

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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female patient at least 18 years old
Patient has menses approximately monthly
Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine

Exclusion criteria

Pregnant and/or nursing
Cardiovascular disease
Uncontrolled hypertension

Treatment and study plan

MK0462, rizatriptan benzoate / Duration of Treatment -1 day

Drug

Comparator: placebo / Duration of Treatment - 1 day

Drug

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 as recorded in patient diary

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: May 25, 2005
Registry last updated: Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed