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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00447772
First received: March 13, 2007
Last updated: July 23, 2009
Last verified: July 2009

March 13, 2007
July 23, 2009
October 2004
February 2008   (final data collection date for primary outcome measure)
Change in Tsui score [ Time Frame: Week 4 versus baseline in week 0 ] [ Designated as safety issue: No ]
Change in Tsui score in week 4 versus baseline in week 0
Complete list of historical versions of study NCT00447772 on ClinicalTrials.gov Archive Site
  • Recording of quality of life (disease specific quality of life questionnaire) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Evaluation of efficacy and safety/tolerability by investigator and patient [ Time Frame: Week 4, 12 ] [ Designated as safety issue: Yes ]
  • Documentation of the dose and of the injection protocol for any subsequent injections [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Descriptive analysis of subgroups [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Tsui score profile (while patient is sitting) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Optional: additional determination of Tsui score (while patient is walking) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Comparison of Tsui scores with patient sitting and patient walking [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cervical Dystonia
Drug: Botulinum type A toxin (Dysport®)
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Experimental: 1
Intervention: Drug: Botulinum type A toxin (Dysport®)
Hefter H, Kupsch A, Müngersdorf M, Paus S, Stenner A, Jost W; Dysport Cervical Dystonia Study Group. A botulinum toxin A treatment algorithm for de novo management of torticollis and laterocollis. BMJ Open. 2011 Jan 1;1(2):e000196. doi: 10.1136/bmjopen-2011-000196.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
April 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • De novo patients with cervical dystonia
  • Outpatient
  • Patients to be of age 18 years or older
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Pre-treatment of cervical dystonia with botulinum toxin
  • Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months
  • Pure retro- or antecollis
  • Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00447772
A-94-52120-098
No
Bert Van Eijk, Ipsen
Ipsen
Not Provided
Study Director: Bert Van Eijk, MD Ipsen
Ipsen
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP