Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia

Phase 3

Completed

Conditions: Cervical Dystonia

Registration Number: NCT00447772

Lead Sponsor: Ipsen

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 516

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
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	The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question). The mean changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
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	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 Week 12 visit is presented.
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	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 changes in the total score of the Tsui rating scale (patient walking) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
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	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). A higher score for each subscale represents severe CD symptoms. 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 changes in the subscores A to D of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
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	The CDQ-24 is a disease-specific quality of life (QoL) instrument and was assessed at Visits 1 to 3. It consists of 24 items investigating problems in daily living skills related to CD. This instrument is based on 5 subscales: Stigma, Emotional well-being, Pain, Activities of daily living (ADL), Social/family life to which a number of the 24 items are assigned. There are five possible answers to each item representing increasing severity of impairment (scores 0 to 4). The total scores ranged from 0 to 96 (best to worst QoL). In order to obtain scores of the individual subscales, the total score of each subscale (sum of the individual item scores) was transformed linearly to a 0 to 100 scale (best to worst QoL). The mean changes in the CDQ-24 total score between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.
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	The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question). The following categorical changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented: Improvement, No change and Deterioration.
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 pain was assessed at Visit 2 (Week 4) and Visit 3 (Week 12); investigators and patients assessed change in global pain according to the following response categories: 1. = no pain (anymore) 2. = less pain 3. = no change 4. = more pain The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.
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	At Visit 2 (Week 4) and Visit 3 (Week 12) investigators and patients assessed global efficacy of injection of 500 U Dysport® according to the following response categories: 1. = very good 2. = good 3. = moderate 4. = insufficient The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.

Trial Locations

Locations (83): Krankenhaus der Barmherzigen Brüder
🇦🇹
Graz, Austria
NÖ LKH Grimmenstein-Hochegg
🇦🇹
Grimmenstein, Austria
Univ.-Klinik für Neurologie
🇦🇹
Innsbruck, Austria
Konventhospital der Barmherzigen Brüder
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Linz, Austria
O.Ö. Landes-Nervenklinik Wagner-Jauregg
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Linz, Austria
Neurolog. Klinik des RWTH Aachen
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Aachen, Germany
Praxis für Anästhesiologie
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Ahaus, Germany
Praxis für Neurologie und Psychiatrie
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Ostfildern, Germany
Sächsisches Krankenhaus
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Arnsdorf, Germany
Praxis für Neurologie
🇩🇪
Stralsund, Germany
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Krankenhaus der Barmherzigen Brüder
🇦🇹Graz, Austria