Phase 3
N=134
Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT01753310 ↗Enrolled (actual)
134
Serious AEs
3.8%
Results posted
Mar 2017
Primary outcome: Primary: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. — 42.5; 42.4; 31.7; 39.9 units on a scale — p=<0.001
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
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4. |
42.5; 42.4; 31.7; 39.9 | <0.001 sig |
| SECONDARY Change From Baseline in TWSTRS Total Score at Week 2. |
42.1; 42.4; 34.5; 39.8 | =0.001 sig |
| SECONDARY Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2. |
1.2; -0.0 | <0.001 sig |
| SECONDARY TWSTRS Responders at Week 2. |
27.9; 11.4 | =0.033 sig |
| SECONDARY Change From Baseline in CGIC in CD at Week 4. |
1.2; 0.1 | <0.001 sig |
| SECONDARY TWSTRS Responders at Week 4. |
41.9; 11.1 | <0.001 sig |
| SECONDARY Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4. |
-8.5; -4.7 | =0.174 |
| SECONDARY Change From Baseline in CDIP-58 Total Score at Week 2. |
-5.8; -4.3 | =0.583 |
Summary
The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL dilution compared with placebo for the treatment of Cervical Dystonia.
Eligibility Criteria
Inclusion Criteria
- Primary diagnosis of Cervical Dystonia at least 9 months since onset and either previously untreated with botulinum toxin or currently treated with Botox at a total dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last injection cycle, and having had a satisfactory treatment response in the principal investigator's judgment during the last two sequential Botox treatment cycles.
- TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;
Exclusion Criteria
- In apparent remission from Cervical Dystonia
- Diagnosis of pure retrocollis or pure anterocollis
- For non-naïve subjects, previous poor response to either of the last two Botox treatments
- Known requirement of 200U of Botox injected into the neck muscles
Data sourced from ClinicalTrials.gov (NCT01753310). 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.