Study to Test a Marketed Drug in the Treatment of Menstrual Migraine - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00111709

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 -1 day Drug: Comparator: placebo / Duration of Treatment - 1 day	Phase III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Menstruation Migraine

Drug Information available for: Rizatriptan Rizatriptan Benzoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

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 as recorded in patient diary

Enrollment:	393
Study Start Date:	June 2005

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111709

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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_024, MK0462-071
Study First Received:	May 24, 2005
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00111709 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Serotonin Agonists
Neurotransmitter Agents
Benzoates
Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Rizatriptan
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Headache Disorders, Primary

Rizatriptan
Brain Diseases
Pharmacologic Actions
Headache Disorders
Serotonin Agents
Migraine Disorders

ClinicalTrials.gov processed this record on May 07, 2009