Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

January 11, 2012 updated by: Clinvest

A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine

Subjects enrolled at 2 investigative sites will complete 3 visits. Following Visit 1, during a 1-month Baseline Period, subjects will treat with their usual medication and document any warning signs (Prodrome pre-headache) that a migraine will occur. Following randomization (like a flip of the coin) at Visit 2, subjects will treat daily with topiramate or during Prodrome with frovatriptan. Subjects complete a 2-month Treatment Period before exit at Visit 3.This study will compare the effectiveness of daily treatment vs. treatment during the pre-headache phase for prevention of migraine.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

55

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

    • Florida
      • Oviedo, Florida, United States, 32765
        • Physician Associates LLC
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  1. Subject has at least a one-year history of migraine with or without aura meeting International Headache Society criteria (see Appendix)
  2. Subject has a 3-month history of averaging 3-6 migraines per month
  3. Subject reports premonitory symptoms and the ability to predict at least 50% of high impact headaches
  4. Subjects must currently or have in the past successfully utilized a triptan as an acute treatment for migraine as determined by the investigator.
  5. Male or female at least 18 years of age
  6. Subject of childbearing potential agrees to use adequate contraception during the study. Adequate methods of contraception are to be determined by the investigator and should be consistent with contraceptive care administered in the regular clinical use of frovatriptan and topiramate.
  7. Subject is aware of prodrome symptoms that may include physiological, psychological or cognitive changes. These may include, but are not limited to such symptoms as Pre-Menstrual Syndrome (PMS), change in mood, energy level, appetite, food craving, nausea, sense of hearing, sense of smell or swelling/fluid retention, excessive yawning, head pain, muscle pain/tenderness, irritability, confusion, extreme sleepiness, impaired speech or impaired memory. (The subject should be able to differentiate these symptoms from other similar symptoms that do not precede migraine). The symptoms should precede migraine by 4-24 hours signaling an impending migraine attack.
  8. Subject is able to understand instructions for the study and complete the diary
  9. Subject is willing to give informed consent to participate in the study
  10. Any migraine prophylactic medication must have a stabilized dosage for one month

EXCLUSION CRITERIA

  1. History of any medical condition that would confound the results of the study including but not limited to the following:

    • Hepatic disease or significant hepatic dysfunction
    • History of pancreatitis
    • History of thrombocytopenia
    • History of glaucoma
    • History of osteoporosis or osteopenia
    • Cardiovascular Disease - Coronary artery disease, Ischemic heart disease or Significant Arrhythmia
    • History of active Cerebrovascular Disease
    • Hypertension - Uncontrolled hypertension in a non-migrainous state (> 160 mmHg systolic or >95 mmHg. diastolic). Hypertension must be controlled effectively with medication for a period of 3 months.
    • Basilar or Hemiplegic Migraine
    • Significant peripheral vascular disease or Raynaud's Syndrome
    • Significant Active Renal, Hepatic, Gastrointestinal, Endocrine or
    • Neurological Disease
    • History of depression, mood problems or suicidal thoughts or behavior that in the opinion of the Investigator would interfere with participation in the study.
  2. History of ergotamine, "triptan", or analgesic abuse within past 3 months
  3. History of current or recent drug or alcohol abuse that would interfere with participation in the study.
  4. More than 15 headache days per month within past 3 months.
  5. Women who are pregnant or breast feeding
  6. Subjects with known hypersensitivity or intolerance to topiramate or any triptan-like medication
  7. Subject is scheduled for surgical procedure to occur while enrolled in study.that in opinion of the Investigator would interfere with participation in the study.
  8. Subject is on a ketogenic diet
  9. Participation in another investigative drug study within the previous 30 days
  10. Excluded medications: MAO Inhibitors, lithium, methylergonovine, methysergide, ergotamine-containing products, or topiramate daily for migraine prophylaxis.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: topiramate
Subjects randomized to Group A at Visit 2 were provided with topiramate, titrated over 4 weeks to a maximum dose of 100 mg daily. One dosage adjustment was allowed with a minimum dose of 50 mg daily.
topiramate 25mg 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 1 tab in PM x 1 week topiramate 25mg 1 tab in AM / 2 tabs in PM x 1 week topiramate 25mg 2 tabs in AM / 2 tabs in PM x 5 weeks
Other Names:
  • Topamax
Active Comparator: frovatriptan
Subjects randomized to Group B at Visit 2 were provided with frovatriptan 5 mg to treat during prodrome at the point they were confident a disabling migraine would occur (before the onset of headache).
frovatriptan 5mg tab during premonitory phase of migraine
Other Names:
  • Frova

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate
Time Frame: Treatment Month 2
Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2
Treatment Month 2
Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine
Time Frame: Treatment Month 2
Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine
Treatment Month 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Headache Days Each Month Following Initiation of Treatment With Study Medication
Time Frame: 2 Months
Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication
2 Months
Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Time Frame: 2 Months
Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2
2 Months
Quality of Life in Subjects Utilizing Each Treatment Paradigm
Time Frame: Randomization, End of Treatment Month 1, End of Treatment Month 2
Quality of Life is measured by the Migraine Specific Quality of Life Questionnaire (MSQ), which includes 3 dimensions: Role Function Restrictive (degree to which performance of daily activities is limited), Role Function Preventive (degree to which performance of daily activities is interrupted), and Emotional Function (frustration and helplessness due to migraine). Scores range from 0 to 100. For each dimension, a higher score indicates a better health status. Participants completed the MSQ at Randomization, and after Treatment Months 1 and 2.
Randomization, End of Treatment Month 1, End of Treatment Month 2
Participant Satisfaction With Study Medications
Time Frame: Treatment Month 2

Participant satisfaction is measured by the Patient Perception of Migraine Questionnaire (PPMQ). Questions were categorized within 6 dimensions: Efficacy, Functionality, Ease of Use, Cost, Bothersomeness of Side Effects, and Total Score. Scores range from 0 to 100. Higher scores represent better satisfaction.

Participants completed the PPMQ 24 hours following each first dose of frovatriptan.

Treatment Month 2
Adverse Events Associated With Study Medications
Time Frame: Treatment Months 1 and 2
Includes Adverse Events at or above 5% frequency per group.
Treatment Months 1 and 2
Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
Time Frame: Treatment Months 1 and 2
Average cost of study medication taken by each subject. Measured in dollars.
Treatment Months 1 and 2

Collaborators and Investigators

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

Sponsor

Collaborators

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.

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

August 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (Estimate)

February 18, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

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 topiramate

3
Subscribe