A Phase 3b, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Ipsen
- Enrollment
- 134
- Locations
- 42
- Primary Endpoint
- Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 <100U or >200U of Botox injected into the neck muscles
Arms & Interventions
Placebo
Placebo, up to 2mL
Intervention: Placebo (Drug)
Dysport®
Dysport® (intramuscular injection), between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
Intervention: Botulinum toxin type A (Biological)
Outcomes
Primary Outcomes
Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score at Week 4.
Time Frame: 4 weeks post-treatment
The change from baseline in the TWSTRS total score at Week 4 was determined for the subjects who received a single dose of Dysport® or placebo by intramuscular injection at the baseline visit (Day 1), and is expressed as weighted overall treatment difference. The TWSTRS is an assessment scale used to measure the impact of CD on subjects, and comprises 3 subscales: severity, disability and pain, each of which is scored independently. The total score from the 3 subscales gives the TWSTRS total score with a value from 0 to 85 (best to worst). The score was assessed by the investigator prior to study treatment at baseline and at all post-treatment visits.
Secondary Outcomes
- Change From Baseline in Cervical Dystonia Impact Profile-58 (CDIP-58) Total Score at Week 4.(4 weeks post-treatment)
- Change From Baseline in CDIP-58 Total Score at Week 2.(2 weeks post-treatment)
- Change From Baseline in TWSTRS Total Score at Week 2.(2 weeks post-treatment)
- Change From Baseline in Clinical Global Impression of Change (CGIC) in CD at Week 2.(2 weeks post-treatment)
- TWSTRS Responders at Week 2.(2 weeks post-treatment)
- Change From Baseline in CGIC in CD at Week 4.(4 weeks post-treatment)
- TWSTRS Responders at Week 4.(4 weeks post-treatment)