Status:
COMPLETED
Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
Lead Sponsor:
Ipsen
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an appro...
Detailed Description
The primary study objectives will be assessed in terms of improvement of the subject's CD at a pre-defined time point after treatment. The primary study objectives are to demonstrate the superiority o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT01261611
Start Date
April 1 2011
End Date
June 1 2013
Last Update
September 28 2022
Active Locations (57)
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1
Monash Medical Centre
Clayton, Australia
2
Austin Hospital
Heidelberg, Australia
3
Department of Neurosciences Alfred Hospital
Prahran, Australia
4
Westmead Hospital
Westmead, Australia