Prospective Survey of Menstrual Migraine & Prevention With Eletriptan - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	Pfizer
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00259649

Purpose

Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Condition	Intervention	Phase
Migraine	Drug: eletriptan	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Assessment and Prevention of Menstrual Migraine: Phase 1-prospective Survey of Self-identified Menstrual Migraine. Phase 2-prevention of Menstrual Migraine With Relpax

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Menstruation Migraine

Drug Information available for: Eletriptan Eletriptan Hydrobromide

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Change in Mean Headache Index Score Among Patients [ Time Frame: baseline to approximately three months ] [ Designated as safety issue: No ]
Headache index is an average headache severity score recorded using a 0-10 severity scale recorded 4 times daily. Scores are averaged to produce an average severity score which can range between 0 (no headaches) to 10 (always a maximum severity headache). Change in headache activity was evaluated by comparing mean severity scores during the 3 months pre-intervention are compared with 3 months of preventive therapy

Enrollment:	71
Study Start Date:	August 2004
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days

Other Name: Relpax

Detailed Description:

Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

age 18-45 healthy menstruating female

Exclusion Criteria:

cardiac or other conditions precluding use of eletriptan

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259649

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206

Sponsors and Collaborators

University of Pittsburgh

Pfizer

Investigators

Principal Investigator:

Dawn Marcus, MD

University of Pittsburgh

More Information

No publications provided

Responsible Party:	Dawn marcus, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00259649 History of Changes
Other Study ID Numbers:	901423
Study First Received:	November 26, 2005
Results First Received:	May 26, 2011
Last Updated:	July 1, 2011
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
Eletriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012