Status:
COMPLETED
Open-label Extension 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 assess longer term safety and effectiveness of Dysport®.
Eligibility Criteria
Inclusion
- Subjects enrolled in the Y-47-52120-051 study, who have completed all study visits up to Week 12, or up to Week 4 in the event of an early withdrawal
- Returned to pre-treatment status as judged by the Investigator
Exclusion
- Pure anterocollis or pure retrocollis
- Known antibodies to botulinum toxin type A
- Requirement for botulinum toxin injections to site(s) other than the neck and unable to avoid such treatment for the duration of the study
- Known significant underlying swallowing or respiratory abnormality which might be exacerbated by botulinum toxin treatment
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00288509
Start Date
February 1 2006
End Date
January 1 2008
Last Update
September 28 2022
Active Locations (18)
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1
Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
3
USC School of Medicine
Los Angeles, California, United States, 90033
4
University of Florida, Dept of Neurology
Gainesville, Florida, United States, 32610