Safety and Tolerability of Frovatriptan to Prevention of Menstrually Associated Migraine (MAM) Headaches

Last updated: December 29, 2023
Sponsor: Endo Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Migraine (Adult)

Pain

Pain (Pediatric)

Treatment

Frovatriptan 2.5 mg

Clinical Study ID

NCT01035983
VML 251-3MAM03
  • Ages > 15
  • Female

Study Summary

In this open-label, multi-center study, patients were treated with frovatriptan for a maximum of 12 perimenstrual periods (PMPs). For each PMP, dosing commenced 2 days before the anticipated onset of the menstrual migraine (MM) headache and continued for a total of 6 days. Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6. During the study, patients were to visit the study site a total of 6 times. Efficacy and/or safety assessments were performed at each visit.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with atleast a 12 month documented history of experiencing migraine according to IHScriteria, including confirmation of a 3 month diary based documented history of MAM.
  • An average frequency of MAM in at least two out of three menstrual cycles, within theprevious 12 months
  • Regular, predictable menstrual periods
  • MAM headaches occurring between Day -2 and day +4 of menses
  • Able and willing to sign informed consent and to comply with study procedures,including completion of the diary cards.

Exclusion

Exclusion Criteria:

  • More than three migraine attacks per month that were not MAM attacks
  • A history of myocardial infarction, ischemic heart disease (or presenting withsymptoms or signs compatible with ischemic heart disease), coronary vasospasm orperipheral vascular disease
  • Significant cerebrovascular disease including basilar or hemiplegic migraine
  • Uncontrolled hypertension (SBP >180 mmHg, DBP >95 mmHg)
  • Severe hepatic or renal insufficiency
  • More than 15 headache days per month, exclusive of migraine headache
  • Any other condition or serious illness which, in the opinion of the investigator,would interfere with optimal participation in the study
  • A history of clinically relevant allergy, including that to frovatriptan or othertriptans
  • Pregnant or breast-feeding, or intending to become pregnant or breast-feed during thestudy period (patients were to be using adequate contraception and have a negativepregnancy test at screening)
  • Treatment with another investigational drug within 30 days or 5 half-lives (whicheverwas longer) before the screening visit
  • Any change in their oral contraceptive medication (if applicable) in the 2 monthsprior to screening, or anticipation of any change during study participation
  • Any change in the type or dose of any prophylactic migraine medication in the 2 monthsprior to screening, or anticipation of any change during study participation
  • A history of migraine with aura, according to IHS criteria, and currently treated witha combined oral contraceptive (South Africa only).

Study Design

Total Participants: 550
Treatment Group(s): 1
Primary Treatment: Frovatriptan 2.5 mg
Phase: 3
Study Start date:
December 01, 2003
Estimated Completion Date:
June 30, 2005

Study Description

This Phase IIIb, open label, multi-centre study evaluated the safety and tolerability of frovatriptan taken by patients for up to 12 perimenstrual periods (PMPs) for the prevention of menstrual migraine (MM). The study required approximately 300 patients to treat 6 PMPs and 100 patients to treat 12 PMPs. To achieve these numbers, 550 patients were to be enrolled into the study. Once enrolled, patients were requested to treat at least 6 PMPs in the first 9 months and 12 PMPs overall. Patients were to remain in the study for a maximum of 15 months or until they had completed the treatment of 12 PMPs, whichever occurred sooner.Patients were to take a loading dose of frovatriptan 5 mg (two tablets) twice daily on Day 1, followed by frovatriptan 2.5 mg twice daily on Days 2-6.

Connect with a study center

  • Munich,
    Germany

    Site Not Available

  • Budapest,
    Hungary

    Site Not Available

  • Warsaw,
    Poland

    Site Not Available

  • Cape Town,
    South Africa

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

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