Overview

Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia

Status:
Completed
Trial end date:
0000-00-00
Target enrollment:
108
Participant gender:
Both
Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ipsen
Treatments:
abobotulinumtoxinA
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Last 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