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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00111722

First received: May 24, 2005

Last updated: May 20, 2013

Last verified: May 2013

History of Changes

Purpose

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

Condition	Intervention	Phase
Migraine	Drug: MK0462, rizatriptan benzoate / Duration of Treatment -1day Drug: Comparator: placebo / Duration of Treatment - 1 day	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Menstruation Migraine

Drug Information available for: Potassium benzoate Rizatriptan Rizatriptan benzoate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	393
Study Start Date:	May 2005
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111722

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Mannix L, Loder E, Nett R, Mueller L, Rodgers A, Hustad C, Ramsey K, Skobieranda F. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007 May;27(5):414-21.

Nett R, Mannix LK, Mueller L, Rodgers A, Hustad CM, Skobieranda F, Ramsey KE. Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. Headache. 2008 Sep;48(8):1194-201. Epub 2008 Apr 14.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00111722 History of Changes
Other Study ID Numbers:	2005_025, MK0462-072
Study First Received:	May 24, 2005
Last Updated:	May 20, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Migraine Disorders
Premenstrual Syndrome
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Menstruation Disturbances
Pathologic Processes
Benzoates

Rizatriptan
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013

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