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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00111722

First received: May 24, 2005

Last updated: March 31, 2017

Last verified: March 2017

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 Intervention Model: Parallel Assignment Masking: Participant, 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:

MedlinePlus related topics: Menstruation Migraine

Drug Information available for: Rizatriptan Rizatriptan benzoate

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Actual Study Start Date:	May 27, 2005
Study Completion Date:	February 23, 2006
Primary Completion Date:	February 15, 2006 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

Mannix LK, Loder E, Nett R, Mueller L, Rodgers A, Hustad CM, Ramsey KE, 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. doi: 10.1111/j.1526-4610.2008.01093.x. Epub 2008 Apr 14.

Study Data/Documents: CSR Synopsis This link exits the ClinicalTrials.gov site


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00111722 History of Changes
Other Study ID Numbers:	0462-072 2005_025
Study First Received:	May 24, 2005
Last Updated:	March 31, 2017

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 18, 2017

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