Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment) Of Menstrual Migraine

February 12, 2010 updated by: Endo Pharmaceuticals

Effectiveness And Safety Of Frovatriptan For The Management (Acute Treatment)Of Menstrual Migraine

Females 18 years of age or older with at least one year history of menstrual migraine (MM) headaches participated in a Phase 4 clinical trial to evaluate the efficacy of frovatriptan when used at the early stage (International Headache Society [IHS] Grade 1) of MM compared with patients' current treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Stratford, Connecticut, United States
    • Florida
      • Clearwater, Florida, United States
      • Jacksonville, Florida, United States
      • Largo, Florida, United States
      • Tampa, Florida, United States
    • New Jersey
      • Blackwood, New Jersey, United States
    • New York
      • New York, New York, United States
      • Plainview, New York, United States
      • Vestal, New York, United States
    • North Carolina
      • Burlington, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • West Chester, Ohio, United States
    • Pennsylvania
      • Norristown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • St. Petersburg, Pennsylvania, United States
      • Upland, Pennsylvania, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Had MM headaches occurring between Day -2 and Day +3 of menses
  2. Had at least one year history of MM headaches
  3. Had at least 8 MM headaches in the previous 12 menstrual cycles (1 year)
  4. Had regular predictable menstrual periods (28 ± 4 days)

Exclusion Criteria:

  1. Had a history of more than 15 headache days per month
  2. As part of current MM treatment, used intermittent prevention with an analgesic (e.g., naproxen for 5 days to prevent the onset of MM)
  3. Had a history of myocardial infarction, ischemic heart disease (or presented with symptoms or signs compatible with ischemic heart disease), coronary vasospasm (including Prinzmetal's variant angina), other significant underlying cardiovascular disease, or peripheral vascular disease
  4. Had significant cerebrovascular disease, including basilar or hemiplegic migraine
  5. Had uncontrolled hypertension: systolic blood pressure >180mmHg and diastolic blood pressure >95mmHg
  6. Had severe hepatic or renal insufficiency
  7. Used an analgesic medication (including both prescription and over-the-counter) for any reason >50% of days per month

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Frovatriptan
Frovatriptan 2.5 mg oral tablet
Drug: Frovatriptan

This study employed a prospective, non-randomized, open-label single-sequence design. The study was conducted in two phases:

  1. A Usual Care phase (approximately 1 month in duration) included one menstrual period during which female patients treated all episodes of migraine headaches using their current treatment (referred to as the Baseline phase in the protocol)
  2. An Acute Treatment phase (approximately 1 month in duration), following the Usual Care phase, included one menstrual period during which female patients used frovatriptan 2.5 mg to treat all episodes of migraine headache when their headache reached IHS Grade 1. If needed, a second dose of frovatriptan 2.5 mg was administered; however, this second dose could not be administered within 2 hours of the initial dose (i.e., there must have been at least 2 hours between doses of frovatriptan). The total daily dose of frovatriptan was not to exceed 3 tablets over a 24-hour period.
Active Comparator: Usual Care
Usual care includes the current treatment used to treat all episodes of migraine headache
Drug: Usual Care
Current treatment used to treat all migraine headaches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache pain severity
Time Frame: Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)
Visit - V1(Day 0), V2 (Day 28), V3 (Day 56)

Secondary Outcome Measures

Outcome Measure
Patient satisfaction with treatment
Occurrence and severity of MM symptoms associated with migraine headache pain (nausea, vomiting, photophobia, and phonophobia)
Occurrence and severity of functional impairment during menstrual migraine
Use of rescue medication and additional frovatriptan dose
Patient preference of current vs. study treatment (end of study only)
Safety as assessed by occurrence of AEs

Collaborators and Investigators

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

Sponsor

Endo Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2005

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 18, 2009

First Posted (Estimate)

May 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 15, 2010

Last Update Submitted That Met QC Criteria

February 12, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN3266-401

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.

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