The objective of this study is to assess the effectiveness and safety of topiramate in the prevention of basilar and hemiplegic migraine in children and adolescents.
The objective of this study is to assess the efficacy and safety of topiramate in the prophylaxis of basilar migraine and hemiplegic migraine in children and adolescents, by comparing two doses, 25 and 100 mg/day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
40
Monarch Medical Research - Child and Adolescent Neurology
Norfolk, Virginia, United States
The primary efficacy outcome will be the reduction in average monthly migraine-days over the entire double-blind phase relative to the prospective baseline period
Reduction in frequency, severity and duration of basilar or hemiplegic aura symptoms
Reduction in migraine pain severity and duration
Reduction in migraine episode and headache episode frequency
Reduction in total headache days
Proportion of responders (i.e., the proportion of subjects who experience a ≥ 50% reduction in migraine-days and migraine episodes)
Cumulative reduction in frequency of migraine days and migraine episodes
Reduction in the use of acute/abortive medications
Reduction in migraine-associated symptoms
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