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

NCT01035983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2024-01-02

No results posted yet for this 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.

Conditions

Interventions

DRUG

Frovatriptan 2.5 mg

Sponsors & Collaborators

  • Vernalis (R&D) Ltd

    collaborator INDUSTRY

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Anne MacGregor, DIPM MFFP · City of London Migraine Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2005-06-30
Completion
2005-06-30

Countries

  • Germany
  • Hungary
  • Poland
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01035983 on ClinicalTrials.gov