Prospective Survey of Menstrual Migraine & Prevention With Eletriptan

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT00259649
• Collaborator: Pfizer (Industry)
• Enrollment: 71
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: eletriptan	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Aug 1, 2004
• Actual Primary Completion Date: Aug 1, 2008

Outcome Measures

Primary Outcome Measures

1. Change in Mean Headache Index Score Among Patients [baseline to approximately three months]

   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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• age 18-45 healthy menstruating female

Exclusion Criteria:

• cardiac or other conditions precluding use of eletriptan

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15206

Sponsors and Collaborators

• University of Pittsburgh
• Pfizer

Investigators

• Principal Investigator: Dawn Marcus, MD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00259649
• Other Study ID Numbers: 901423
• First Posted: Nov 29, 2005
• Last Update Posted: Jul 4, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Migraine Disorders; Eletriptan

Study Results

Participant Flow

Arm/Group Title	Eletriptan
Arm/Group Description	Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
Period Title: Overall Study
STARTED	71
COMPLETED	61
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Eletriptan
Arm/Group Description	Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
Overall Participants	71
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	71 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	71 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	71 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Eletriptan
Arm/Group Description	Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
Measure Participants	71
Mean (Standard Error) [headache index score]	-1.52 (0.05)

Adverse Events

Adverse Event Reporting Description	71 participants were enrolled in the study. Five did not receive treatment or attend their initial follow-up assessment. Therefore, AE data were only available for 66 participants.
Arm/Group Title	Eletriptan
Arm/Group Description	Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
All Cause Mortality
	Eletriptan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Eletriptan
	Affected / at Risk (%)	# Events
Total	0/66 (0%)
Other (Not Including Serious) Adverse Events
	Eletriptan
	Affected / at Risk (%)	# Events
Total	0/66 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.