NCT00259649

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 4, 2011

Completed
Last Updated

July 4, 2011

Status Verified

June 1, 2011

Enrollment Period

4 years

First QC Date

November 26, 2005

Results QC Date

May 26, 2011

Last Update Submit

July 1, 2011

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline to approximately three months

Interventions

eletriptanDRUG

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

Also known as: Relpax

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 18-45 healthy menstruating female

You may not qualify if:

  • cardiac or other conditions precluding use of eletriptan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

eletriptan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

Relatively small sample size and open-label treatment limit Menstrual regulation by hormonal therapy might have affected treatment response;

Results Point of Contact

Title
Dawn marcus
Organization
University of Pittsburgh
marcusd@upmc.edu
412-953-4797

Study Officials

  • Dawn Marcus, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2005

First Posted

November 29, 2005

Study Start

August 1, 2004

Primary Completion

August 1, 2008

Last Updated

July 4, 2011

Results First Posted

July 4, 2011

Record last verified: 2011-06

Locations

US(1)