Multicentre Open Study on the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cervical Dystonia
- Sponsor
- Ipsen
- Enrollment
- 516
- Locations
- 83
- Primary Endpoint
- 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)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
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
Outcomes
Primary Outcomes
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)
Time Frame: Baseline to Week 4 or Week 12 (up to 12 weeks)
The Tsui rating scale measures severity and duration of head deviation, shoulder elevation and head tremor. This instrument is based on 4 subscores: * Subscore A: amplitude of rotation, deflection (tilt) and ante- / retrocollis (range: 0-9 points) * Subscore B: duration of movement (values 1 or 2) * Subscore C: severity and duration of shoulder elevation (range: 0-3 points) * Subscore D: severity and duration of tremor (range: 0-4 points). The total score was calculated as follows: total score = subscores (A x B) + C + D. The total score ranges between 0 and 25 points. A high total score represents severe CD. The mean change in the total score of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the first on-treatment visit (Week 4 or Week 12 visit) is presented.
Secondary Outcomes
- 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)(Baseline to Week 4 and Week 12)
- Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)(Baseline to Week 12)
- 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)(Baseline to Week 4 and Week 12)
- 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)(Baseline to Week 4 and Week 12)
- 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)(Baseline to Week 4 and Week 12)
- 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)(Baseline to Week 4 and Week 12)
- 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)(Week 4 visit and Week 12 visit)
- Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)(Week 4 and Week 12)