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:

  1. 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.
  2. double blind, randomised, multi center, crossover study

Detailed Summary:

  1. Prospective, randomized, head-to-head, double-blind, cross-over study.
  2. Total patients: A group 51, B group 51
  3. 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)
  4. 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 ]

Tsui scale (range: 0-25, higher values represent worse cervical dystonia.) Negative numbers to represent decreases of Tsui scale.


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