Phase 3
N=116
Randomized, Placebo-Controlled Study of AbobotulinumtoxinA (Dysport®) for the Treatment of Cervical Dystonia
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT00257660 ↗Enrolled (actual)
116
Serious AEs
0.9%
Results posted
May 2010
Primary outcome: Primary: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) — -13.99; -5.23; 43.83; 45.81 points on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin type A (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) |
-13.82; -5.59; 43.83; 45.81; 29.31; 39.64 | <0.0001 sig |
| SECONDARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) |
-13.82; -5.59; 43.83; 45.81; 29.31; 39.64 | <0.0001 sig |
| SECONDARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score |
-6.98; -4.53; 43.83; 45.81; 36.04; 40.76 | 0.019 sig |
| SECONDARY Subject Visual Analogue Score (VAS) for Cervical Dystonia (CD) Symptom Assessment |
-24.2; -6.7; 67.7; 63.6; 44.3; 55.7 | <0.001 sig |
| SECONDARY Investigator VAS for CD Symptom Assessment |
-23.1; -9.1; 62.3; 65.3; 40.3; 56.8 | <0.001 sig |
| SECONDARY Subject VAS for CD Symptom Assessment |
-14.4; -4.6; 67.7; 63.6; 55.4; 58.2 | 0.007 sig |
| SECONDARY Investigator's VAS for CD Symptom Assessment |
-8.5; -5.8; 62.3; 65.3; 54.8; 60.0 | 0.028 sig |
| SECONDARY Subject VAS for CD Symptom Assessment |
-14.4; -4.6; 67.7; 63.6; 55.4; 58.2 | 0.007 sig |
| SECONDARY Investigator's VAS for CD Symptom Assessment |
-8.5; -5.8; 62.3; 65.3; 54.8; 60.0 | 0.028 sig |
| SECONDARY SF-36 Mental Health Summary Score |
4.11; 2.48; 44.52; 43.31; 49.00; 43.41 | 0.061 |
| SECONDARY SF-36 Physical Health Summary Score |
4.37; -0.64; 39.42; 43.18; 43.70; 42.49 | 0.002 sig |
| SECONDARY Number of Participants Considered by the Investigator to be Overall Treatment Successes |
32; 10 | <0.0001 sig |
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 Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00257660). 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.