Back to resultsProspective Survey of Menstrual Migraine & Prevention With Eletriptan
Primary Purpose
Migraine
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
eletriptan
Sponsored by
About this trial
This is an interventional prevention trial for Migraine
Eligibility Criteria
Inclusion Criteria: age 18-45 healthy menstruating female Exclusion Criteria: cardiac or other conditions precluding use of eletriptan
Sites / Locations
- University of Pittsburgh
Outcomes
Primary Outcome Measures
Change in Mean Headache Index Score Among Patients
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00259649
First Posted
November 26, 2005
Last Updated
July 1, 2011
Sponsor
University of Pittsburgh
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00259649
Brief Title
Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
Collaborators
Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
eletriptan
Other Intervention Name(s)
Relpax
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Mean Headache Index Score Among Patients
Description
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
Time Frame
baseline to approximately three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 18-45 healthy menstruating female
Exclusion Criteria:
cardiac or other conditions precluding use of eletriptan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Marcus, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prospective Survey of Menstrual Migraine & Prevention With Eletriptan
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