Trial record 1 of 1 for:    A-TL-52120-169
Previous Study | Return to List | Next Study

A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD).

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Ipsen
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01753310
First received: December 17, 2012
Last updated: August 21, 2014
Last verified: August 2014

December 17, 2012
August 21, 2014
January 2013
September 2014   (final data collection date for primary outcome measure)
Change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score [ Time Frame: 4 weeks post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01753310 on ClinicalTrials.gov Archive Site
  • Change from baseline in TWSTRS total score [ Time Frame: Baseline and 2 weeks post-treatment ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Change (CGIC) in Cervical Dystonia [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
  • Treatment response [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
    A treatment responder is defined as a subject who had at least a 30% reduction in the TWSTRS total score after treatment.
  • Change in Cervical Dystonia Impact Profile-58 (CDIP-58) score [ Time Frame: 2 and 4 weeks post-treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomised Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia (CD).
A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT Using 2mL Dilution in Adults With Cervical Dystonia.

The purpose of the protocol is to evaluate the efficacy of Dysport using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cervical Dystonia
  • Drug: Dysport
    Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
  • Drug: Placebo, Up to 2mL
  • Active Comparator: Dysport
    Dysport (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
    Intervention: Drug: Dysport
  • Placebo Comparator: Placebo
    Up to 2mL
    Intervention: Drug: Placebo, Up to 2mL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
September 2014
September 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
  • TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion Criteria:

  • In apparent remission from Cervical Dystonia
  • Diagnosis of pure retrocollis or pure anterocollis
  • For non-naïve subjects, previous poor response to either of the last two Botox treatments
  • Known requirement of <100U or >200U of Botox injected into the neck muscles
Both
18 Years and older
No
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
United States
 
NCT01753310
A-TL-52120-169
No
Ipsen
Ipsen
Not Provided
Study Director: Kathleen G Lomax, M.D. Ipsen
Ipsen
August 2014

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