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

NCT00644033 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 579

Last updated 2024-01-02

No results posted yet for this study

Summary

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.

Conditions

  • Menstrually Associated Migraine

Interventions

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.

DRUG

Placebo

placebo tablet administered for 6 days, starting 2 days before the anticipated onset of a MAM headache.

Sponsors & Collaborators

  • Vernalis (R&D) Ltd

    collaborator INDUSTRY

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Arthur Elkind, MD · Elkind Headache Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-06-30
Primary Completion
2002-06-30
Completion
2002-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00644033 on ClinicalTrials.gov