Overall trial objectives: 1. Can treatment with tonabersat reduce the number of days with aura and/or migraine headache in patients with migraine with aura 2. How well tolerated is treatment with tonabersat The study is based on the hypothesis that the unique mechanism of action of tonabersat will inhibit some of the early events in the generation of aura and migraine headache and so be effective as prophylactic treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
39
two tablets once daily
two tablets once daily
Danish Headache Centre, Department of Neurology, Glostrup Hospital
Copenhagen, Denmark
Difference in the mean number of aura attacks experienced between treatment groups
Time frame: 12 week treatment period
Difference in the mean number of migraine headache days between treatment groups
Time frame: 12 week treatment period
Incidence of adverse events
Time frame: 12 week treatment period
Mean number of headache days in each treatment period.
Time frame: 12 week treatment period
Mean number of auras followed by headache in each treatment period.
Time frame: 12 week treatment period
Mean number of headache days in each month of treatment in each treatment period.
Time frame: Mean monthly
Mean number of auras and/or migraine headache during each treatment period.
Time frame: 12 week treatment period
Mean number of migraine headache attacks in each treatment period.
Time frame: 12 week treatment period
Speed of effect of treatment.
Time frame: First month for which difference between treatments identified
Mean monthly consumption of rescue medication.
Time frame: Mean monthly
Mean duration of auras in each treatment period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Mean over 12 week treatment period
Mean number of symptoms associated with auras in each treatment period.
Time frame: 12 week treatment period