Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study
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.
Migraine Without Aura Prophylaxis
Drug: Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A 12-Week Prospective, Double-Blinded, Randomized, Multicenter Study of Low Dose and Medium Dose Botulinum Toxin Type A (Dysport® ) Injection for Migraine Prophylaxis.|
- 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
|Study Start Date:||February 2003|
|Estimated Study Completion Date:||June 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258609
|Division of Neurology, Department of Medicine, Bhumipol Hospital.|
|Division of Neurology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University|
|Division of Neurology, Department of Medicine, Pramongkutklao Hospital|
|Division of Neurology, Prasart Neurological Institute, Public Health Ministry.|
|Northern Neurological Center, Faculty of Medicine, Chiang Mai University|
|Chiang Mai, Thailand, 50200|
|Department of Medicine, Sappasithiprasong Hospital, Public Health Ministry|
|Principal Investigator:||Siwaporn Chankrachang, MD||Northern Neurological Center, Faculty of Medicine,Chiang Mai University|