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

NCT01035983 | Completed Phase 3 DMC

• 1 other identifier: VML 251-3MAM03
• Study Type: interventional
• Target: 550
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Migraine

Keywords

menstrually associated migraine (MAM), Migraines,Menstrual Migraines, menstrually related migraines

Outcome Measures

Primary Outcomes (1)

• Incidence of all treatment-emergent adverse events (AEs).

  9-15 months

Secondary Outcomes (10)

• Incidence of menstrual migraine headache

  9-15 months

• Maximum headache severity

  9-15 months

• Number of headache-free days during a treated perimenstrual period (PMP)

  9-15 months

• Occurrence and severity of menstrual migraine headache-associated symptoms

  9-15 months

• Maximum functional impairment during menstrual migraine headache

  9-15 months

Study Arms (1)

Frovatriptan 2.5 mg

EXPERIMENTAL

Frovatriptan 2.5 mg tablets administered orally 2 x 2.5 mg twice daily (loading dose) on day 1, followed by 2.5 mg twice daily days 2 to 6.

Drug: Frovatriptan 2.5 mg

Interventions

Frovatriptan 2.5 mg DRUG

Frovatriptan 2.5 mg

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged 15 years and over (≥18 years in United Kingdom and South Africa), with at least a 12 month documented history of experiencing migraine according to IHS criteria, 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 the previous 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.

You may not qualify if:

• More than three migraine attacks per month that were not MAM attacks
• A history of myocardial infarction, ischemic heart disease (or presenting with symptoms or signs compatible with ischemic heart disease), coronary vasospasm or peripheral 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 other triptans
• Pregnant or breast-feeding, or intending to become pregnant or breast-feed during the study period (patients were to be using adequate contraception and have a negative pregnancy test at screening)
• Treatment with another investigational drug within 30 days or 5 half-lives (whichever was longer) before the screening visit
• Any change in their oral contraceptive medication (if applicable) in the 2 months prior 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 months prior to screening, or anticipation of any change during study participation
• A history of migraine with aura, according to IHS criteria, and currently treated with a combined oral contraceptive (South Africa only).

Sponsors & Collaborators

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

Study Sites (5)

Unknown Facility

Munich, Germany

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Cape Town, South Africa

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

• MacGregor EA, Brandes JL, Silberstein S, Jeka S, Czapinski P, Shaw B, Pawsey S. Safety and tolerability of short-term preventive frovatriptan: a combined analysis. Headache. 2009 Oct;49(9):1298-314. doi: 10.1111/j.1526-4610.2009.01513.x.

  PMID: 19788471 RESULT

MeSH Terms

Conditions

Migraine Disorders; Limb-girdle muscular dystrophy, type 2C

Interventions

frovatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anne MacGregor, DIPM MFFP

  City of London Migraine Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: December 1, 2003
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

GB (1); PL (1); ZA (1); DE (1); HU (1)