Study Comparing Short Term Efficacy of Dysport® and Dysport RU® to Placebo, and to Assess Efficacy and Safety of Dysport RU® of Subjects With Cervical Dystonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01261611
First received: December 15, 2010
Last updated: February 27, 2014
Last verified: February 2014

December 15, 2010
February 27, 2014
April 2011
May 2012   (final data collection date for primary outcome measure)
Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261611 on ClinicalTrials.gov Archive Site
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia following first treatment [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Proportion of treatment responders [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) disability score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) pain sub-scale score for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for pain from Cervical Dystonia for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Change in Subject Visual Analogue Score (VAS) for symptoms of Cervical Dystonia for treatment cycles 2 to 5 [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
  • Proportion of treatment responders [ Time Frame: Treatment cycle Baseline and Week 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study Comparing Short Term Efficacy of Dysport® and Dysport RU® to Placebo, and to Assess Efficacy and Safety of Dysport RU® of Subjects With Cervical Dystonia
A Phase III, Randomised, Double-blind and Open Label Phase, Active and Placebo Controlled Study Comparing the Short Term Efficacy of Two Formulations of Clostridium Botulinum Type A Toxin (Dysport® and Dysport RU®) to Placebo, and Assessing the Short and Long Term Efficacy and Safety of Dysport RU® Following Repeated Treatments of Subjects With Cervical Dystonia

The purpose of this study is to evaluate how well a new drug called Dysport RU works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport RU will be compared to an approved drug called Dysport.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cervical Dystonia
  • Drug: Botulinum type A toxin (Dysport RU®)
    I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.
  • Drug: Botulinum type A toxin (Dysport®)
    I.M. injection on day 1 of treatment cycle 1.
  • Drug: Placebo
    I.M. injection on day 1 of treatment cycle 1.
  • Experimental: Dysport RU

    500U (1ml) administered as intramuscular injection on day 1 of treatment cycle 1 and 2.

    250U (0.5ml), 500U (1ml) or 750U (1.5ml) administered as intramuscular injection on day 1 of treatment cycle 3.

    250U (0.5ml), 500U (1ml), 750U (1.5ml) or 1000U (2ml) administered as intramuscular injection on day 1 of treatment cycle 4 and 5.

    Intervention: Drug: Botulinum type A toxin (Dysport RU®)
  • Active Comparator: Dysport
    500U (1ml) injected as intramuscular injection on day 1 of treatment cycle 1.
    Intervention: Drug: Botulinum type A toxin (Dysport®)
  • Placebo Comparator: Placebo
    1ml administered as, intramuscular injection on day 1 of treatment cycle 1.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
333
May 2013
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Dystonia with at least 18 months duration since onset.
  • Previously untreated with Botulinum toxin-A (BTX-A) or -B or a minimum of 14 weeks since the last injection.
  • TWSTRS score at baseline of: Total score ≥ 30, Severity Sub-Scale score ≥ 15, Disability Sub-Scale score ≥ 3, Pain Sub-Scale score ≥ 2.

Exclusion Criteria:

  • Known hypersensitivity to Botulinum toxin (BTX) or related compounds or any component in the study drug formulation (including cow milk protein).
  • Pure anterocollis or pure retrocollis.
  • In apparent remission from Cervical Dystonia.
  • Known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.
  • Previous poor response to BTX treatment or known presence of BTX neutralising antibodies.
  • Previous phenol or alcohol injections into the neck muscles.
  • Previous myotomy or denervation surgery involving the neck or shoulder region.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Ukraine,   France,   Czech Republic,   Poland,   Portugal,   Hungary,   Germany,   Russian Federation,   Austria
 
NCT01261611
Y-52-52120-134, 2010-019907-43
No
Ipsen
Ipsen
Not Provided
Study Director: Ipsen Study Director Ipsen
Ipsen
February 2014

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