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Completed

NCT Number: NCT00644033

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

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.

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Key information

Conditions

Menstrually Associated Migraine

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Endo Pharmaceuticals

Chadds Ford, Pennsylvania, 19317, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

frovatriptan

Drug

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

Placebo

Drug

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

Primary outcomes

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

Secondary outcomes

  1. Incidence of moderate or severe MAM headaches

  2. Incidence of severe MAM headaches

  3. Duration of MAM headaches

  4. Maximum headache intensity

  5. Incidence of MAM headache associated symptoms and characteristics

  6. Duration of MAM headache associated symptoms

  7. Maximum functional impairment score during MAM headache

  8. Incidence of moderate or severe functional impairment during MAM headache

  9. Duration of moderate or severe functional impairment during MAM headache

  10. Incidence of use of rescue medication for the treatment of a MAM headache

  11. Patient satisfaction score at the end of each 6 day treated PMP

  12. Adverse events

  13. Standard hematology and biochemistry

  14. 12-lead ECGs, physical exam, vital signs

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Collaborators

  • Vernalis (R&D) Ltd

Registry information

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Mar 26, 2008
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.