Overview
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Status:
Completed
Completed
Trial end date:
0000-00-00
0000-00-00
Target enrollment:
108
108
Participant gender:
Both
Both
Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport®.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
IpsenTreatments:
abobotulinumtoxinA
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinALast Updated:
2010-06-17
Criteria
Inclusion Criteria:- 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 Criteria:
- 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