Status:
COMPLETED
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Lead Sponsor:
Ipsen
Conditions:
Cervical Dystonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
Eligibility Criteria
Inclusion
- Cervical dystonia with at least 18 months since onset, and previously untreated with botulinum toxin or previously treated with botulinum toxin type A or B with a minimum interval of 16 weeks since the last injection and having returned at least to their usual pre-treatment status
- TWSTRS severity, disability and total scores meeting the defined criteria at baseline
Exclusion
- Pure anterocollis or pure retrocollis
- In apparent remission from cervical dystonia
- Previous poor response to the last two botulinum toxin type A or type B treatments
- Being treated with type B toxin due to lack of efficacy to type A toxin or have known neutralizing antibodies to type A toxin
Key Trial Info
Start Date :
October 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00257660
Start Date
October 10 2005
End Date
September 1 2006
Last Update
September 28 2022
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
2
Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States
3
USC School of Medicine
Los Angeles, California, United States, 90033
4
University of Florida
Gainesville, Florida, United States