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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
55
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
frovatriptan 5mg tab during premonitory phase of migraine
Physician Associates LLC
Oviedo, Florida, United States
Clinvest
Springfield, Missouri, United States
Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate
Compare number of migraine attacks reported by participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate during Treatment Period Month 2
Time frame: Treatment Month 2
Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine
Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine
Time frame: Treatment Month 2
Number of Headache Days Each Month Following Initiation of Treatment With Study Medication
Measure the change in number of headache days reported by participants during each treatment month following initiation of treatment with study medication
Time frame: 2 Months
Participants With Greater Than 50% Reduction in Migraine Attacks and Headache Days Per Month Utilizing Each Treatment Paradigm
Compare number of participants with greater than 50% reduction in migraine attacks and headache days from Baseline to Treatment Months 1 and 2
Time frame: 2 Months
Quality of Life in Subjects Utilizing Each Treatment Paradigm
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.
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Time frame: Randomization, End of Treatment Month 1, End of Treatment Month 2
Participant Satisfaction With Study Medications
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.
Time frame: Treatment Month 2
Adverse Events Associated With Study Medications
Includes Adverse Events at or above 5% frequency per group.
Time frame: Treatment Months 1 and 2
Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine
Average cost of study medication taken by each subject. Measured in dollars.
Time frame: Treatment Months 1 and 2