Clinical Trial: Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open Multicentre Study to Demonstrate the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia

Brief Summary: The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome: Change in Tsui score [ Time Frame: Week 4 versus baseline in week 0 ]

Original Primary Outcome: Change in Tsui score in week 4 versus baseline in week 0

Current Secondary Outcome:

  • Recording of quality of life (disease specific quality of life questionnaire) [ Time Frame: Week 0, 4, 12 ]
  • Evaluation of efficacy and safety/tolerability by investigator and patient [ Time Frame: Week 4, 12 ]
  • Documentation of the dose and of the injection protocol for any subsequent injections [ Time Frame: Week 12 ]
  • Descriptive analysis of subgroups [ Time Frame: Week 0, 4, 12 ]
  • Tsui score profile (while patient is sitting) [ Time Frame: Week 0, 4, 12 ]
  • Optional: additional determination of Tsui score (while patient is walking) [ Time Frame: Week 0, 4, 12 ]
  • Comparison of Tsui scores with patient sitting and patient walking [ Time Frame: Week 0, 4, 12 ]


Original Secondary Outcome:

  • Recording of quality of life in week 0, 4, 12 (disease specific quality of life questionnaire)
  • Evaluation of efficacy and safety/tolerability by investigator and patient
  • Documentation of the dose and of the injection protocol for any subsequent injections
  • Descriptive analysis of subgroups
  • Tsui score profile over weeks 0, 4 and 12 (while patient is sitting)
  • Optional: additional determination of Tsui score (while patient is walking)
  • Comparison of Tsui scores with patient sitting and patient walking


Information By: Ipsen

Dates:
Date Received: March 13, 2007
Date Started: October 2004
Date Completion:
Last Updated: July 23, 2009
Last Verified: July 2009