Clinical Trial: A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Double Blind, Randomized, Multi-center, Cross-over Study to Demonstrate the Non-inferiority of Dysport® (abobotulinumtoxinA) in the Clinical Efficacy and Safety in Comparison With Botox®(o
Brief Summary:
- to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
- double blind, randomised, multi center, crossover study
Detailed Summary:
- Prospective, randomized, head-to-head, double-blind, cross-over study.
- Total patients: A group 51, B group 51
- Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
- Compare the TSUI change score from baseline to 4 weeks after injection.
Sponsor: Seoul National University Hospital
Current Primary Outcome: Reduction of Total Tsui Score at 4 Weeks From Baseline [ Time Frame: 4 weeks after injection from baseline ]
Original Primary Outcome: TSUI score change [ Time Frame: from baseline to 4 weeks after injection. ]
Current Secondary Outcome:
- Reduction of Total TWSTRS Score at 4 Weeks From Baseline [ Time Frame: 4 weeks after injection from baseline ]TWSTRS (Toronto western spasmodic torticollis rating scale) (range: 0-80, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of TWSTRS.
- CGI-I (Clinical Global Impression of Illness) [ Time Frame: 4, 8, 12 and 16 weeks after injection ]
The proportion of patients with 'normal/ not at all ill' or 'borderline mildly ill' on the CGI (Clinical global impression of illness, CGI-I)
1 = normal / not at all ill'; 2 = 'borderline mildly ill'; 3 = 'mildly ill'; 4 = 'moderlately ill'; 5 = 'markedly ill'; 6 = 'severely ill'; 7 = 'the most extremely ill'.
- PGI-I (Patient's Global Impression of Improvement) [ Time Frame: 4, 8, 12 and 16 weeks after injection ]
The proportion of patients with 'very much improved' or 'much improved' on the PGI (Patient's global impression of impairment, PGI-I)
1 = very much improved, 2= much improved, 3 = slightly improved, 4 = no change, 5 = slightly aggravated, 6 = much aggravated, and 7 = very much aggravated
Original Secondary Outcome:
- pain reduction associated with CD using TWSTRS score, duration of action and the change of signs and symptoms of Cervical dystonia. [ Time Frame: 4 weeks after injection ]
- safety of Dysport® and Botox® [ Time Frame: 4 months after injection ]
Information By: Seoul National University Hospital
Dates:
Date Received: July 29, 2009
Date Started: August 2009
Date Completion:
Last Updated: August 5, 2013
Last Verified: August 2013