Phase 3
N=108
Open-label Extension Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT00288509 ↗Enrolled (actual)
108
Serious AEs
1.8%
Results posted
Apr 2010
Primary outcome: Primary: Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline — -16.21; 42.48; 25.81; -11.40 points on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin type A (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Toronto Western Spasmodic Torticollis Rating Scale Total Score From Baseline |
-16.21; 42.48; 25.81; -11.40; 34.72; 23.40 | — |
| SECONDARY Toronto Western Spasmodic Torticollis Rating Scale Severity Subscale as a Change From Baseline |
-7.68; 19.79; 11.90; -5.52; 16.05; 10.54 | — |
| SECONDARY Toronto Western Spasmodic Torticollis Rating Scale Disability Subscale Score as a Change From Baseline |
-4.25; 12.70; 8.51; -2.88; 10.45; 7.63 | — |
| SECONDARY Toronto Western Spasmodic Torticollis Rating Scale Pain Subscale Score as a Change From Baseline |
-4.53; 10.08; 5.37; -2.99; 8.12; 5.22 | — |
Summary
The aim of this study is to assess longer term safety and effectiveness of Dysport®.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00288509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.