Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00259649
First received: November 26, 2005
Last updated: July 1, 2011
Last verified: June 2011
  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 4

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:


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:
    Drug: eletriptan
    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
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: 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
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 September 22, 2014