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

Phase 4

Completed

• Conditions: Migraine
• Interventions: Drug: topiramate; Drug: frovatriptan

• Registration Number: NCT00846495
• Lead Sponsor: Clinvest

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Study Start: 2009-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2011-06-09
• Results First Submitted QC: 2011-07-12
• Results First Posted: 2011-08-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-11
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topiramate	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.
frovatriptan	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).

Primary Outcome Measures

Name	Time	Method
Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate	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
Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine	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

Secondary Outcome Measures

Name	Time	Method
Number of Headache Days Each Month Following Initiation of Treatment With Study Medication	2 Months	Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication
Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm	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
Quality of Life in Subjects Utilizing Each Treatment Paradigm	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.
Participant Satisfaction With Study Medications	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.
Adverse Events Associated With Study Medications	Treatment Months 1 and 2	Includes Adverse Events at or above 5% frequency per group.
Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine	Treatment Months 1 and 2	Average cost of study medication taken by each subject. Measured in dollars.

Trial Locations

Locations (2)

Physician Associates LLC; 🇺🇸 Oviedo, Florida, United States

Clinvest; 🇺🇸 Springfield, Missouri, United States