Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine (NCT00846495) | Clinical Trial Compass
CompletedPhase 4
Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine
United States55 participantsStarted 2009-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject has at least a one-year history of migraine with or without aura meeting International Headache Society criteria (see Appendix)
✓. Subject has a 3-month history of averaging 3-6 migraines per month
✓. Subject reports premonitory symptoms and the ability to predict at least 50% of high impact headaches
✓. Subjects must currently or have in the past successfully utilized a triptan as an acute treatment for migraine as determined by the investigator.
✓. Male or female at least 18 years of age
✓. 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.
✓. 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.
What they're measuring
1
Number of Migraine Attacks in Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate
Timeframe: Treatment Month 2
2
Number of Headache Days Reported by Participants Using Frovatriptan in a Preemptive Treatment Paradigm vs. Daily Topiramate to Prevent Migraine
✓. Subject is able to understand instructions for the study and complete the diary
Exclusion criteria
✕. History of any medical condition that would confound the results of the study including but not limited to the following:
✕. History of ergotamine, "triptan", or analgesic abuse within past 3 months
✕. History of current or recent drug or alcohol abuse that would interfere with participation in the study.
✕. More than 15 headache days per month within past 3 months.
✕. Women who are pregnant or breast feeding
✕. Subjects with known hypersensitivity or intolerance to topiramate or any triptan-like medication
✕. 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.