Chronic Migraine Clinical Trial
Official title:
NINDS Clinical Research Collaboration Chronic Migraine Treatment Trial
The purpose of this study is to compare the reduction in the number of severe headache days at six months in people with chronic migraine treated with topiramate and propranolol versus those treated with topiramate and a placebo.
Chronic migraine affects about 2 percent of all adults. Currently there are no effective
preventative treatments to deal with this disabling condition. Three randomized,
placebo-controlled trials found that topiramate was an effective, safe and generally
well-tolerated drug for treating chronic migraine. As a result of these trials, topiramate
is becoming the standard treatment among headache specialists. Experts agree that treatment
with combinations of preventive agents is required in the majority of individuals with
chronic migraine for maximal headache relief. No randomized trials have assessed the value
of frequently used combinations of preventive agents for chronic migraine.
The goal of this trial is to determine if adding a second drug to topiramate treatment will
further reduce the headache burden for people with this condition. In the study, 250
participants with chronic migraine will be randomized to two groups - treatment with
topiramate and propranolol or topiramate and placebo. Participants will be followed for six
months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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