Clinical Trial: Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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.
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Rajavithi Hospital
Current Primary Outcome:
- 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
Original Primary Outcome:
- Mean change from baseline of Total Headache score.
- Mean change from baseline of duration of migraine attack ( hours)
- Mean change from baseline of duration of migraine frequency
Current Secondary Outcome: MIDAS score, SF36
Original Secondary Outcome: Same as current
Information By: Rajavithi Hospital
Dates:
Date Received: November 23, 2005
Date Started: February 2003
Date Completion: June 2004
Last Updated: December 22, 2005
Last Verified: December 2005
