The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A are effective in the treatment of migraine without aura prophylaxis.
This is a 12-week, prospective double-blinded, randomized, multicenter study of placebo, 120 Unit, and 240 unit of botulinum toxin A ( Dysport ® ) injection for patient with a diagnosis of Migraine without aura according to International Headache Society criteria. It is designed to evaluate the efficacy, safety, tolerability and optimum dose of Botulinum toxin type A (Dysport ®)injection for migraine without aura prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
128
Division of Neurology, Department of Medicine, Bhumipol Hospital.
Bangkok, Thailand
Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand
Division of Neurology, Department of Medicine, Pramongkutklao Hospital
Bangkok, Thailand
Division of Neurology, Prasart Neurological Institute, Public Health Ministry.
Mean change from baseline of Area undercurve of headache diary ( total headache score).
Mean change from baseline of total duration of migraine attack( hours) in 4 weeks.
Mean change from baseline of migraine frequency
MIDAS score, SF36
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Bangkok, Thailand
Northern Neurological Center, Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand
Department of Medicine, Sappasithiprasong Hospital, Public Health Ministry
Ubonratchatani, Thailand