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

Primary Purpose

Cervical Dystonia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Botulinum toxin type A

About this trial

This is an interventional treatment trial for Cervical Dystonia focused on measuring Dysport, Cervical Dystonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Krankenhaus der Barmherzigen Brüder
NÖ LKH Grimmenstein-Hochegg
Univ.-Klinik für Neurologie
Konventhospital der Barmherzigen Brüder
O.Ö. Landes-Nervenklinik Wagner-Jauregg
Neurolog. Klinik des RWTH Aachen
Praxis für Anästhesiologie
Praxis für Neurologie und Psychiatrie
Sächsisches Krankenhaus
Praxis für Neurologie
Klinikum für Rehabilitation
Praxis für Neurologie
Krankenhaus Hohe Warte
Neurologische Rehabilitationsklinik
NRZ Neurologisches Rehabilitationszentrum Leipzig
Praxis für Neurologie
Neurologisches Facharztzentrum am St.-Gertrauden-KH
Praxis für Neurologie
Universitätsklinikum Charité, Campus Benjamin Franklin
Universitätsklinikum Charité, Campus Virchow-Klinikum
Gemeinschaftspraxis für Neurologie
Krankenhaus Henningsdorf
SALUS Fachkrankenhaus Bernburg
Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB
Praxis für Neurologie
Berufsg. Kliniken Bergmannsheil
St.-Josef-Hospital
Medizinische Einrichtung Rhein. F.-Wilhelms-Universität Bonn
Zentralkrankenhaus Bremen-Ost
Klinikum Chemnitz gGmbH
Praxis für Neurologie
Bezirksklinikum Mainkofen
Universitätsklinikum Carl Gustav Carus
Malteser Krankenhaus St. Anna
University Hospital, Neurology Clinic
Landesklinik Eberswalde
HELIOS Klinikum Erfurt
Uniklinik Erlangen
Alfried-Krupp-Krankenhaus
Universitätsklinik Essen
Kreiskrankenhaus Freiberg
Zentrum für Neurologie
Praxis für Neurologie und Psychiatrie
Praxis für Neurologie
Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie
Bezirkskrankenhaus Günzburg
Klinikum Ambrock
Katholisches Krankenhaus Hagen
Städt. Krankenhaus Martha-Maria
Gemeinschaftspraxis für Neurologie
Praxis für Neurologie
Neurologische Uniklinik
Praxis für Neurologie
Universitätskliniken des Saarlandes
Gemeinschaftspraxis für Neurologie/Psychiatrie
Praxis für Neurologie
Uniklinik Jena
Westpfalz-Klinikum GmbH
Universitätsklinikum Kiel
Kath. Klinikum/Brüderkrankenhaus
Klinikum Koeln-Merheim
Neurologische Praxis
Universitätsklinikum Leipzig
Gemeinschaftspraxis für Neurologie/Psychiatrie
Gemeinschaftspraxis für Neurologie
Klinikum Lippe-Lemgo GmbH
Klinikum der Stadt Ludwigshafen
Universitätsklinikum
Gemeinschaftspraxis für Neurologie/Psychiatrie
Universitätsklinikum
Universitätsklinikum
Klinikum Mannheim
Praxis für Neurologie
Klinikum Minden
Kliniken Maria Hilf GmbH
Neurologisches Krankenhaus München
Klinikum rechts der Isar
Universitätsklinikum Münster
Praxis für Neurologie und Nervenheilkunde
Klinikum Nürnberg-Süd
Evangelisches Krankenhaus Oldenburg
Praxis für Neurologie und Psychiatrie
St. Vincenz-Krankenhaus GmbH
St.-Josefs-Krankenhaus
Klinikum Ernst von Bergmann
Zentrum für Psychiatrie Weissenau
Knappschafts-Krankenhaus
Universitätsklinikum
Evang.-Freichkirchl. Krankenhaus
Praxis für Neurologie
Klinikum Uckermark GmbH
HELIOS Kliniken Schwerin
Asklepios Kliniken Schildautal
EMSA
Landesfachkrankenhaus für Psychatrie und Neurologie
Praxis für Neurologie
Neurologische Praxis
Landesklinik Teupitz
Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung
Klinikum Weiden
Stiftung Deutsche Klinik für Diagnostik
Gemeinschaftspraxis für Neurologie
Klinikum Wuppertal
Medizinisches Studienzentrum
Universitätsklinikum Würzburg
Paracelsus Klinik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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)

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

Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (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)

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)

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)

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.

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)

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.

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)

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)

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: = no pain (anymore) = less pain = no change = 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)

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: = very good = good = moderate = 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.

Full Information

NCT ID

NCT00447772

First Posted

March 13, 2007

Last Updated

March 3, 2023

Sponsor

Ipsen

1. Study Identification

Unique Protocol Identification Number

NCT00447772

Brief Title

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

Official Title

Multicentre Open Study on the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ipsen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Dystonia

Keywords

Dysport, Cervical Dystonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

516 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Botulinum toxin type A

Other Intervention Name(s)

AbobotulinumtoxinA (Dysport®)

Intervention Description

Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia

Primary Outcome Measure Information:

Title

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)

Description

Time Frame

Baseline to Week 4 or Week 12 (up to 12 weeks)

Secondary Outcome Measure Information:

Title

Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)

Description

Time Frame

Baseline to Week 12

Title

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)

Description

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.

Time Frame