A Randomized Trial of Frovatriptan for the Intermittent Prevention of Menstrual Migraine

December 29, 2023 updated by: Endo Pharmaceuticals

The primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (MAM) headaches when compared to placebo. Secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of MAM headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of MAM headaches. In this cross-over study, patients treated each of 3 perimenstrual periods (PMPs) with placebo, frovatriptan 2.5 mg daily (QD) and 2.5 mg twice daily (BID) for 6 days, starting 2 days before the anticipated onset of a MAM headache.

A statistically significant reduction in the incidence of MAM headache (p<0.0001) was observed with both dosing regimens of frovatriptan when compared to placebo. Additionally, the frovatriptan BID regimen was superior to the frovatriptan QD regimen in the prevention of MAM headache (p<0.001). Significant reductions in MAM headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the PMP was treated with frovatriptan, compared to placebo. Both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

579

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Endo Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Females aged 18 years and over
  • 12 month or more documented history of menstrual migraine headache, according to International Headache Society classification
  • An average frequency of MAM attacks in at lease 3 out of 4 menstrual cycles
  • Regular predictable menstrual periods
  • Able to accurately predict the onset of MAM headaches occurring between Day -2 and Day +4 of menses
  • Able and willing to sign informed consent to comply with study procedures, including completion of diary cards

Exclusion Criteria:

  • More than three migraine attacks per month that were not MAM attacks
  • Coronary artery disease including coronary vasospasm
  • Significant cerebrovascular disease including basilar or hemiplegic migraine
  • Uncontrolled hypertension
  • Severe hepatic or renal insufficiency
  • More than 15 headache days per month
  • Any other condition or serious illness which would interfere with optimal participation in the study
  • History of clinically relevant allergy, including that to frovatriptan or other triptans
  • Pregnant or breast feeding or intending to become pregnant or to breast-feed during study period
  • Participated in other frovatriptan menstrual migraine prevention studies
  • Use of another investigation drug within 30 days or 5 half-lives (whichever is longer) before the screening visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: Frovatriptan
2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
Drug: Frovatriptan
2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
Active Comparator: 1
Drug: Frovatriptan
2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache
Drug: Frovatriptan
2.5 mg tablet administered twice daily for 6 days, starting 2 days before the anticipated onset of a MAM headache.
Placebo Comparator: 3
Drug: Placebo
placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of menstrually associated migraine (MAM) headache in the treated peri-menstrual period (PMP)

Secondary Outcome Measures

Outcome Measure
Adverse events
Duration of MAM headaches
Maximum headache intensity
Duration of MAM headache associated symptoms
Maximum functional impairment score during MAM headache
Incidence of moderate or severe MAM headaches
Incidence of severe MAM headaches
Incidence of MAM headache associated symptoms and characteristics
Incidence of moderate or severe functional impairment during MAM headache
Duration of moderate or severe functional impairment during MAM headache
Incidence of use of rescue medication for the treatment of a MAM headache
Patient satisfaction score at the end of each 6 day treated PMP
Standard hematology and biochemistry
12-lead ECGs, physical exam, vital signs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Collaborators

Vernalis (R&D) Ltd

Investigators

  • Principal Investigator: Arthur Elkind, MD, Elkind Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

June 1, 2002

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimated)

March 26, 2008

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VML 251 00/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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