A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine

December 29, 2023 updated by: Endo Pharmaceuticals

A Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-related Migraine (MRM) Headaches in a 'Difficult to Treat' Population

Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.

Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See above

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs

Secondary Outcome Measures

Outcome Measure
Maximum headache intensity
Incidence of MRM headache
Incidence of moderate or severe MRM headaches
Number of MRM headache free days during treated PMPs
Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)
Functional impairment during treatment phase
Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endo Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

May 16, 2007

First Submitted That Met QC Criteria

May 17, 2007

First Posted (Estimated)

May 21, 2007

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 29, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VML 251-3MRM02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe