Phase 3
N=369
Study Comparing Short Term Efficacy of Dysport and Dysport NG to Placebo, and to Assess Efficacy and Safety of Dysport NG of Subjects With Cervical Dystonia
Cervical Dystonia
Bottom Line
View on ClinicalTrials.gov: NCT01261611 ↗Enrolled (actual)
369
Serious AEs
2.7%
Results posted
Sep 2019
Primary outcome: Primary: Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle — -12.46; -13.99; -3.93 Units 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
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score Following First Treatment Cycle |
-12.46; -13.99; -3.93 | <0.0001 sig |
| SECONDARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale Score Following First Treatment Cycle |
-6.2; -6.6; -1.9 | — |
| SECONDARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale Score Following First Treatment Cycle |
-3.3; -3.9; -0.8 | — |
| SECONDARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score Following First Treatment Cycle |
-3.10; -3.44; -1.21 | — |
| SECONDARY Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia Following First Treatment Cycle |
-14.8; -19.2; -3.4 | — |
| SECONDARY Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia Following First Treatment Cycle |
-18.7; -23.6; -3.3 | — |
| SECONDARY Percentage of Treatment Responders Following First Treatment Cycle |
45.8; 55.8; 20.8 | — |
| SECONDARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score for Treatment Cycles 2 to 5 |
-15.35; -14.85; -15.58; -15.28 | — |
| SECONDARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Score for Treatment Cycles 2 to 5 |
-7.2; -7.1; -7.3; -7.0 | — |
| SECONDARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Score for Treatment Cycles 2 to 5 |
-4.7; -4.6; -5.0; -4.9 | — |
| SECONDARY Change From Baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale Score for Treatment Cycles 2 to 5 |
-3.45; -3.21; -3.34; -3.41 | — |
| SECONDARY Change From Baseline in Subject Visual Analogue Score (VAS) for Pain From Cervical Dystonia for Treatment Cycles 2 to 5 |
-20.1; -17.8; -18.0; -16.1 | — |
| SECONDARY Change From Baseline in Subject Visual Analogue Score (VAS) for Symptoms of Cervical Dystonia for Treatment Cycles 2 to 5 |
-24.0; -18.9; -21.0; -18.2 | — |
| SECONDARY Percentage of Treatment Responders for Treatment Cycles 2 to 5 |
58.5; 56.8; 63.5; 57.5 | — |
Summary
The purpose of this study is to evaluate how well a new drug called Dysport NG works and how safe it is, when it is used for the treatment of cervical dystonia. Dysport NG will be compared to an approved drug called Dysport.
Eligibility Criteria
Inclusion Criteria
- Dystonia with at least 18 months duration since onset.
- Previously untreated with Botulinum toxin-A (BTX-A) or -B or a minimum of 14 weeks since the last injection.
- TWSTRS score at baseline of: Total score ≥ 30, Severity Sub-Scale score ≥ 15, Disability Sub-Scale score ≥ 3, Pain Sub-Scale score ≥ 2.
Exclusion Criteria
- Known hypersensitivity to Botulinum toxin (BTX) or related compounds or any component in the study drug formulation (including cow milk protein).
- Pure anterocollis or pure retrocollis.
- In apparent remission from Cervical Dystonia.
- Known clinically significant underlying swallowing or respiratory abnormality which might be exacerbated by BTX treatment.
- Previous poor response to BTX treatment or known presence of BTX neutralising antibodies.
- Previous phenol or alcohol injections into the neck muscles.
- Previous myotomy or denervation surgery involving the neck or shoulder region.
Data sourced from ClinicalTrials.gov (NCT01261611). 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.