41007
document
Effects of tonabersat on migraine with aura : a randomised , double-blind , placebo-controlled crossover study . BACKGROUND Migraine with aura is thought likely to be caused by cortical spreading depression ( CSD ) . Tonabersat inhibits CSD , and we therefore investigated whether tonabersat has a preventive effect in migraine with aura . METHODS In this randomised , double-blind , placebo-controlled crossover trial , 40 mg tonabersat once daily was compared with matched placebo in patients who had at least one aura attack per month during the past 3 months . Randomisation was by computer-generated list . Patients kept a detailed diary to enable objective diagnosis of each attack as migraine with aura , migraine without aura , or other type of headache . Primary endpoints were a reduction in aura attacks with or without headache and a reduction in migraine headache days with or without an aura . Analysis was per protocol . This trial is registered , number NCT00332007 . FINDINGS 39 patients were included in the study , of whom 31 were included in the statistical analysis of efficacy . Median ( IQR ) attacks of aura were reduced from 3.2 ( 1.0-5.0 ) per 12 weeks on placebo to 1.0 ( 0-3.0 ) on tonabersat ( p=0.01 ) , whereas the other primary outcome measure , median migraine headache days with or without aura , was not significantly different between placebo and tonabersat groups ( 3.0 days in each group ; p=0.09 ) . Tonabersat was well tolerated but overall had more side-effects than placebo . INTERPRETATION Tonabersat showed a preventive effect on attacks of migraine aura but no efficacy on non-aura attacks , in keeping with its known inhibitory effect on CSD . The results support the theory that auras are caused by CSD and that this phenomenon is not involved in attacks without aura . FUNDING Minster Pharmaceuticals ; Lundbeck Foundation .
41008
Intervention_Pharmacological
tonabersat
41009
Intervention_Pharmacological
Tonabersat
41010
Intervention_Pharmacological
tonabersat
41011
Intervention_Control
compared with matched placebo
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Intervention_Control
placebo
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Intervention_Control
placebo
41014
Intervention_Pharmacological
tonabersat
41015
Intervention_Pharmacological
Tonabersat
41016
Outcome_Physical
reduction in aura attacks with or without headache
41017
Outcome_Physical
reduction in migraine headache days with or without an aura
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Outcome_Physical
Median ( IQR ) attacks of aura
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Outcome_Physical
median migraine headache days with or without aura
41020
Outcome_Other
tolerated
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Participant_Condition
migraine with aura
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Participant_Condition
had at least one aura attack per month during the past 3 months
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Participant_Sample-size
39
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Participant_Sample-size
31 were included in the statistical analysis of efficacy