Pilot Study to Compare Frovatriptan vs. Topiramate for 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||A Randomized, Single-Blind Pilot Study to Compare the Efficacy and Cost-Effectiveness of Frovatriptan vs. Topiramate for the Prevention of Migraine|
- Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate [ Time Frame: Treatment Month 2 ] [ Designated as safety issue: No ]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 [ Time Frame: Treatment Month 2 ] [ Designated as safety issue: No ]Measure the change in number of headache days between participants using frovatriptan in a preemptive treatment paradigm vs. daily topiramate to prevent migraine
- Number of Headache Days Each Month Following Initiation of Treatment With Study Medication [ Time Frame: 2 Months ] [ Designated as safety issue: No ]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 [ Time Frame: 2 Months ] [ Designated as safety issue: No ]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 [ Time Frame: Randomization, End of Treatment Month 1, End of Treatment Month 2 ] [ Designated as safety issue: No ]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 [ Time Frame: Treatment Month 2 ] [ Designated as safety issue: No ]
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 [ Time Frame: Treatment Months 1 and 2 ] [ Designated as safety issue: Yes ]Includes Adverse Events at or above 5% frequency per group.
- Cost of Frovatriptan vs. Topiramate as Preventive Treatment of Migraine [ Time Frame: Treatment Months 1 and 2 ] [ Designated as safety issue: No ]Average cost of study medication taken by each subject. Measured in dollars.
|Study Start Date:||August 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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 Name: 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 Name: Frova
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846495
|United States, Florida|
|Physician Associates LLC|
|Oviedo, Florida, United States, 32765|
|United States, Missouri|
|Springfield, Missouri, United States, 65807|
|Principal Investigator:||Roger K Cady, MD||Clinvest|