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

NCT00644033 | Completed Phase 3

• 1 other identifier: VML 251 00/02
• Study Type: interventional
• Target: 579
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (14)

• Incidence of moderate or severe MAM headaches

• Incidence of severe MAM headaches

• Duration of MAM headaches

• Maximum headache intensity

• Incidence of MAM headache associated symptoms and characteristics

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: Frovatriptan

2

ACTIVE COMPARATOR

Drug: Frovatriptan

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Frovatriptan DRUG

2.5 mg tablet administered once daily for 6 days starting 2 days before the anticipated onset of a MAM headache

1

Placebo DRUG

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

3

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 18 years and over
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead
• Vernalis (R&D) Ltd: collaborator

Study Sites (1)

Endo Pharmaceuticals

Chadds Ford, Pennsylvania, 19317, United States

Location

Related Publications (1)

• Silberstein SD, Berner T, Tobin J, Xiang Q, Campbell JC. Scheduled short-term prevention with frovatriptan for migraine occurring exclusively in association with menstruation. Headache. 2009 Oct;49(9):1283-97. doi: 10.1111/j.1526-4610.2009.01509.x. Epub 2009 Sep 14.

  PMID: 19751371 DERIVED

MeSH Terms

Interventions

frovatriptan

Study Officials

• Arthur Elkind, MD

  Elkind Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 26, 2008
• Study Start: June 1, 2001
• Primary Completion: June 1, 2002
• Study Completion: June 1, 2002
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

US (1)