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Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00833196
First received: January 29, 2009
Last updated: July 6, 2010
Last verified: July 2010
History of Changes

January 29, 2009
July 6, 2010
February 2009
February 2010   (final data collection date for primary outcome measure)
Responder rate at peak effect following one BoNT-A injection cycle without any deviations from routine practice [ Time Frame: Around 4 weeks post injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833196 on ClinicalTrials.gov Archive Site
  • To describe TWSTRS change scores from inclusion (total score & subscales scores) [ Time Frame: Baseline, and around 4 weeks and 3 months post injection ] [ Designated as safety issue: No ]
  • To describe tremor change score from inclusion (TSUI scale) [ Time Frame: Baseline, and around 4 weeks and 3 months post injection ] [ Designated as safety issue: No ]
  • To describe the Cervical Dystonia Impact Profile (CDIP) 58 change from inclusion [ Time Frame: Baseline, and around 4 weeks post injection ] [ Designated as safety issue: No ]
  • To describe subject and investigator's CGI scores [ Time Frame: Around 4 weeks post injection ] [ Designated as safety issue: No ]
  • To identify prognostic factors for response (Exploratory Objective) [ Time Frame: baseline, and around 4 weeks and 3 months post injection ] [ Designated as safety issue: No ]
Same as current
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Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia
Factors Influencing Response to One BoNT-A Injection Cycle in Subjects Suffering From Idiopathic Cervical Dystonia

A post marketing, international, multicenter, observational, prospective, longitudinal study. The purpose of the study is to describe cervical dystonia sub-types with their injection protocols and response to BoNT-A.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with idiopathic cervical dystonia
Idiopathic Cervical Dystonia
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
April 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Idiopathic cervical dystonia
  • TWSTRS severity score ≥ 15
  • At least a 12-week interval between the last injection (BoNT-A or BoNTB) and inclusion
  • Written informed consent prior to collect the data

Exclusion Criteria:

  • Contraindications to any BoNT-A preparations
  • Secondary cervical dystonia
  • Subject already been included in the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Czech Republic,   France,   Germany,   Netherlands,   Portugal,   Russian Federation,   United Kingdom
 
NCT00833196
Y-79-52120-131
No
Benjamin Zakine, Ipsen
Ipsen
Not Provided
Study Director: Benjamin Zakine, MD Ipsen
Ipsen
July 2010

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