Phase 3
Completed N=516
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
Source: ClinicalTrials.gov NCT00447772 ↗Enrolled (actual)
516
Serious AEs
2.1%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) at the First On-treatment Visit (Week 4 or Week 12) — -3.8; -4.0; -3.8 units on a scale — p==0.2552
◆ Published Evidence
Established
41citations · ~3 / year
An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport).
Summary
The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be assigned to one of the two basic types of cervical dystonia, either predominantly rotational torticollis or predominantly laterocollis on the basis of clinical examination. This will determine which therapy is to be administered, using the clearly defined, structured injection protocols.
Linked Publications (2)
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An open-label cohort study of the improvement of quality of life and pain in de novo cervical dystonia patients after injections with 500 U botulinum toxin A (Dysport).
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A botulinum toxin A treatment algorithm for de novo management of torticollis and laterocollis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) at the First On-treatment Visit (Week 4 or Week 12) |
-3.8; -4.0; -3.8 | =0.2552 |
| SECONDARY Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12) |
-2.3; -2.4; -2.3 | — |
| SECONDARY Change in the Total Score of the Tsui Rating Scale (Patient Walking) Between Baseline (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) |
-3.8; -4.3; -3.9; -2.3; -2.3; -2.3 | — |
| SECONDARY Change in the 4 Subscores of the Tsui Rating Scale (Patient in the Sitting Position) Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) |
-1.3; -1.5; -1.4; -0.4; -0.3; -0.3 | — |
| SECONDARY Change in the Craniocervical Dystonia Questionnaire (CDQ-24) Total Score and Subscores Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) |
-11.1; -16.8; -10.3; -11.5; -11.1; -5.6 | — |
| SECONDARY Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) |
-1.1; -0.8; -1.2; -1.1; -0.9; -1.3 | — |
| SECONDARY Categorical Changes in the Items of the Patient Diary Based on Day-to-day Function and Activities, Pain and Duration of Pain Between Visit 1 (Week 0) and Visit 2 (Week 4) and Visit 3 (Week 12) |
59.9; 19.6; 20.5; 50.2; 23.0; 26.8 | — |
| SECONDARY Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) |
131; 205; 94; 70; 142; 227 | — |
| SECONDARY Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12) |
129; 221; 109; 41; 134; 218 | — |
Eligibility Criteria
Inclusion Criteria
- De novo patients with cervical dystonia
- Outpatient
- Patients to be of age 18 years or older
- Written informed consent to participate in the study
Exclusion Criteria
- Pre-treatment of cervical dystonia with botulinum toxin
- Pre-treatment with botulinum toxin for any indication other than cervical dystonia within the past 12 months
- Pure retro- or antecollis
- Neurological or other diseases which may affect head and neck motor function or neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy, motor neurone diseases, Bekhterev's disease
Data sourced from ClinicalTrials.gov (NCT00447772) and the linked publication. 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. Informational only — not medical advice.