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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00447772
Other study ID # A-94-52120-098
Secondary ID 2004-002086-20
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2004
Est. completion date April 2008

Study information

Verified date March 2023
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 516
Est. completion date April 2008
Est. primary completion date February 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria Krankenhaus der Barmherzigen Brüder Graz
Austria NÖ LKH Grimmenstein-Hochegg Grimmenstein
Austria Univ.-Klinik für Neurologie Innsbruck
Austria Konventhospital der Barmherzigen Brüder Linz
Austria O.Ö. Landes-Nervenklinik Wagner-Jauregg Linz
Germany Neurolog. Klinik des RWTH Aachen Aachen
Germany Praxis für Anästhesiologie Ahaus
Germany Praxis für Neurologie und Psychiatrie Apolda
Germany Sächsisches Krankenhaus Arnsdorf
Germany Praxis für Neurologie Aschaffenburg
Germany Klinikum für Rehabilitation Bad Oeynhausen
Germany Praxis für Neurologie Bad Reichenhall
Germany Krankenhaus Hohe Warte Bayreuth
Germany Neurologische Rehabilitationsklinik Beelitz
Germany NRZ Neurologisches Rehabilitationszentrum Leipzig Bennewitz
Germany Gemeinschaftspraxis für Neurologie Berlin
Germany Krankenhaus Henningsdorf Berlin
Germany Neurologisches Facharztzentrum am St.-Gertrauden-KH Berlin
Germany Praxis für Neurologie Berlin
Germany Praxis für Neurologie Berlin
Germany Universitätsklinikum Charité, Campus Benjamin Franklin Berlin
Germany Universitätsklinikum Charité, Campus Virchow-Klinikum Berlin
Germany SALUS Fachkrankenhaus Bernburg Bernburg
Germany Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB Bielefeld
Germany Berufsg. Kliniken Bergmannsheil Bochum
Germany Praxis für Neurologie Bochum
Germany St.-Josef-Hospital Bochum
Germany Medizinische Einrichtung Rhein. F.-Wilhelms-Universität Bonn Bonn
Germany Zentralkrankenhaus Bremen-Ost Bremen
Germany Klinikum Chemnitz gGmbH Chemnitz
Germany Praxis für Neurologie Dachau
Germany Bezirksklinikum Mainkofen Deggendorf
Germany Universitätsklinikum Carl Gustav Carus Dresden
Germany Malteser Krankenhaus St. Anna Duisburg
Germany University Hospital, Neurology Clinic Düsseldorf
Germany Landesklinik Eberswalde Eberswalde
Germany HELIOS Klinikum Erfurt Erfurt
Germany Uniklinik Erlangen Erlangen
Germany Alfried-Krupp-Krankenhaus Essen
Germany Universitätsklinik Essen Essen
Germany Kreiskrankenhaus Freiberg Freiberg
Germany Praxis für Neurologie und Psychiatrie Giessen
Germany Zentrum für Neurologie Giessen
Germany Praxis für Neurologie Gießen
Germany Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie Großschweidnitz
Germany Bezirkskrankenhaus Günzburg Günzburg
Germany Katholisches Krankenhaus Hagen Hagen
Germany Klinikum Ambrock Hagen
Germany Städt. Krankenhaus Martha-Maria Halle
Germany Gemeinschaftspraxis für Neurologie Hamburg
Germany Praxis für Neurologie Hamburg
Germany Neurologische Uniklinik Hannover
Germany Praxis für Neurologie Hannover
Germany Universitätskliniken des Saarlandes Homburg
Germany Gemeinschaftspraxis für Neurologie/Psychiatrie Ilmenau
Germany Praxis für Neurologie Itzehoe
Germany Uniklinik Jena Jena
Germany Westpfalz-Klinikum GmbH Kaiserslautern
Germany Universitätsklinikum Kiel Kiel
Germany Kath. Klinikum/Brüderkrankenhaus Koblenz
Germany Klinikum Koeln-Merheim Koeln
Germany Neurologische Praxis Landshut
Germany Gemeinschaftspraxis für Neurologie Leipzig
Germany Gemeinschaftspraxis für Neurologie/Psychiatrie Leipzig
Germany Universitätsklinikum Leipzig Leipzig
Germany Klinikum Lippe-Lemgo GmbH Lemgo
Germany Universitätsklinikum Lübeck
Germany Klinikum der Stadt Ludwigshafen Ludwigshafen
Germany Gemeinschaftspraxis für Neurologie/Psychiatrie Lüneburg
Germany Universitätsklinikum Magdeburg
Germany Universitätsklinikum Mainz
Germany Klinikum Mannheim Mannheim
Germany Praxis für Neurologie Mannheim
Germany Klinikum Minden Minden
Germany Kliniken Maria Hilf GmbH Mönchengladbach
Germany Klinikum rechts der Isar München
Germany Neurologisches Krankenhaus München München
Germany Universitätsklinikum Münster Münster
Germany Praxis für Neurologie und Nervenheilkunde Neubrandenburg
Germany Klinikum Nürnberg-Süd Nürnberg
Germany Evangelisches Krankenhaus Oldenburg Oldenburg
Germany Praxis für Neurologie und Psychiatrie Ostfildern
Germany St. Vincenz-Krankenhaus GmbH Paderborn
Germany Klinikum Ernst von Bergmann Potsdam
Germany St.-Josefs-Krankenhaus Potsdam
Germany Zentrum für Psychiatrie Weissenau Ravensburg
Germany Knappschafts-Krankenhaus Recklinghausen
Germany Universitätsklinikum Rostock
Germany Evang.-Freichkirchl. Krankenhaus Rüdersdorf
Germany Praxis für Neurologie Schorndorf
Germany Klinikum Uckermark GmbH Schwedt/Oder
Germany HELIOS Kliniken Schwerin Schwerin
Germany Asklepios Kliniken Schildautal Seesen
Germany EMSA Singen
Germany Landesfachkrankenhaus für Psychatrie und Neurologie Stadtroda
Germany Praxis für Neurologie Stralsund
Germany Neurologische Praxis Straubing
Germany Landesklinik Teupitz Teupitz
Germany Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung Tübingen
Germany Klinikum Weiden Weiden
Germany Stiftung Deutsche Klinik für Diagnostik Wiesbaden
Germany Gemeinschaftspraxis für Neurologie Wolfenbüttel
Germany Klinikum Wuppertal Wuppertal
Germany Medizinisches Studienzentrum Würzburg
Germany Universitätsklinikum Würzburg Würzburg
Germany Paracelsus Klinik Zwickau

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (2)

Hefter H, Benecke R, Erbguth F, Jost W, Reichel G, Wissel J. 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). BMJ Open. 2013 Apr 18;3(4 — View Citation

Hefter H, Kupsch A, Mungersdorf M, Paus S, Stenner A, Jost W; Dysport Cervical Dystonia Study Group. A botulinum toxin A treatment algorithm for de novo management of torticollis and laterocollis. BMJ Open. 2011 Jan 1;1(2):e000196. doi: 10.1136/bmjopen-20 — View Citation

Outcome

Type Measure Description Time frame Safety issue
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) 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.
Baseline to Week 4 or Week 12 (up to 12 weeks)
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) 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.
Baseline to Week 12
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) 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.
Baseline to Week 4 and Week 12
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) 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.
Baseline to Week 4 and Week 12
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) 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.
Baseline to Week 4 and Week 12
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) 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.
Baseline to Week 4 and Week 12
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) 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.
Baseline to Week 4 and Week 12
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) 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.
Week 4 visit and Week 12 visit
Secondary 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.
Week 4 and Week 12
See also
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Terminated NCT00760318 - Keppra for Cervical Dystonia Phase 2
Completed NCT00323765 - Plasticity in Cervical Dystonia N/A
Completed NCT04171258 - Clinical Trial to Compare the Safety and Efficacy of Botulax® Versus Botox® in Patients With Cervical Dystonia Phase 1
Completed NCT04849988 - A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia Phase 2
Completed NCT03471923 - Non-Motor Features of Cervical Dystonia (CD)