Clinical trial NCT00447772: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cervical Dystonia
Keywords: Dysport, Cervical Dystonia
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2007-03-15
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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)
timeFrame: Baseline to Week 4 or Week 12 (up to 12 weeks)
Secondary outcomes:
measure: Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (Week 12)
timeFrame: Baseline to Week 12
measure: 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)
timeFrame: Baseline to Week 4 and Week 12
measure: 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)
timeFrame: Baseline to Week 4 and Week 12
measure: 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)
timeFrame: Baseline to Week 4 and Week 12
measure: 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)
timeFrame: Baseline to Week 4 and Week 12
measure: 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)
timeFrame: Baseline to Week 4 and Week 12
measure: 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)
timeFrame: Week 4 visit and Week 12 visit
measure: Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)
timeFrame: Week 4 and Week 12
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Krankenhaus der Barmherzigen Brüder
city: Grimmenstein
country: Austria
facility: NÖ LKH Grimmenstein-Hochegg
city: Innsbruck
country: Austria
facility: Univ.-Klinik für Neurologie
city: Linz
country: Austria
facility: Konventhospital der Barmherzigen Brüder
city: Linz
country: Austria
facility: O.Ö. Landes-Nervenklinik Wagner-Jauregg
city: Aachen
country: Germany
facility: Neurolog. Klinik des RWTH Aachen
city: Ahaus
country: Germany
facility: Praxis für Anästhesiologie
city: Apolda
country: Germany
facility: Praxis für Neurologie und Psychiatrie
city: Arnsdorf
country: Germany
facility: Sächsisches Krankenhaus
city: Aschaffenburg
country: Germany
facility: Praxis für Neurologie
city: Bad Oeynhausen
country: Germany
facility: Klinikum für Rehabilitation
city: Bad Reichenhall
country: Germany
facility: Praxis für Neurologie
city: Bayreuth
country: Germany
facility: Krankenhaus Hohe Warte
city: Beelitz
country: Germany
facility: Neurologische Rehabilitationsklinik
city: Bennewitz
country: Germany
facility: NRZ Neurologisches Rehabilitationszentrum Leipzig
city: Berlin
country: Germany
facility: Praxis für Neurologie
city: Berlin
country: Germany
facility: Neurologisches Facharztzentrum am St.-Gertrauden-KH
city: Berlin
country: Germany
facility: Praxis für Neurologie
city: Berlin
country: Germany
facility: Universitätsklinikum Charité, Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Universitätsklinikum Charité, Campus Virchow-Klinikum
city: Berlin
country: Germany
facility: Gemeinschaftspraxis für Neurologie
city: Berlin
country: Germany
facility: Krankenhaus Henningsdorf
city: Bernburg
country: Germany
facility: SALUS Fachkrankenhaus Bernburg
city: Bielefeld
country: Germany
facility: Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB
city: Bochum
country: Germany
facility: Praxis für Neurologie
city: Bochum
country: Germany
facility: Berufsg. Kliniken Bergmannsheil
city: Bochum
country: Germany
facility: St.-Josef-Hospital
city: Bonn
country: Germany
facility: Medizinische Einrichtung Rhein. F.-Wilhelms-Universität Bonn
city: Bremen
country: Germany
facility: Zentralkrankenhaus Bremen-Ost
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Dachau
country: Germany
facility: Praxis für Neurologie
city: Deggendorf
country: Germany
facility: Bezirksklinikum Mainkofen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Duisburg
country: Germany
facility: Malteser Krankenhaus St. Anna
city: Düsseldorf
country: Germany
facility: University Hospital, Neurology Clinic
city: Eberswalde
country: Germany
facility: Landesklinik Eberswalde
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Erlangen
country: Germany
facility: Uniklinik Erlangen
city: Essen
country: Germany
facility: Alfried-Krupp-Krankenhaus
city: Essen
country: Germany
facility: Universitätsklinik Essen
city: Freiberg
country: Germany
facility: Kreiskrankenhaus Freiberg
city: Giessen
country: Germany
facility: Zentrum für Neurologie
city: Giessen
country: Germany
facility: Praxis für Neurologie und Psychiatrie
city: Gießen
country: Germany
facility: Praxis für Neurologie
city: Großschweidnitz
country: Germany
facility: Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie
city: Günzburg
country: Germany
facility: Bezirkskrankenhaus Günzburg
city: Hagen
country: Germany
facility: Klinikum Ambrock
city: Hagen
country: Germany
facility: Katholisches Krankenhaus Hagen
city: Halle
country: Germany
facility: Städt. Krankenhaus Martha-Maria
city: Hamburg
country: Germany
facility: Gemeinschaftspraxis für Neurologie
city: Hamburg
country: Germany
facility: Praxis für Neurologie
city: Hannover
country: Germany
facility: Neurologische Uniklinik
city: Hannover
country: Germany
facility: Praxis für Neurologie
city: Homburg
country: Germany
facility: Universitätskliniken des Saarlandes
city: Ilmenau
country: Germany
facility: Gemeinschaftspraxis für Neurologie/Psychiatrie
city: Itzehoe
country: Germany
facility: Praxis für Neurologie
city: Jena
country: Germany
facility: Uniklinik Jena
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel
city: Koblenz
country: Germany
facility: Kath. Klinikum/Brüderkrankenhaus
city: Koeln
country: Germany
facility: Klinikum Koeln-Merheim
city: Landshut
country: Germany
facility: Neurologische Praxis
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis für Neurologie/Psychiatrie
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis für Neurologie
city: Lemgo
country: Germany
facility: Klinikum Lippe-Lemgo GmbH
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen
city: Lübeck
country: Germany
facility: Universitätsklinikum
city: Lüneburg
country: Germany
facility: Gemeinschaftspraxis für Neurologie/Psychiatrie
city: Magdeburg
country: Germany
facility: Universitätsklinikum
city: Mainz
country: Germany
facility: Universitätsklinikum
city: Mannheim
country: Germany
facility: Klinikum Mannheim
city: Mannheim
country: Germany
facility: Praxis für Neurologie
city: Minden
country: Germany
facility: Klinikum Minden
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: München
country: Germany
facility: Neurologisches Krankenhaus München
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Neubrandenburg
country: Germany
facility: Praxis für Neurologie und Nervenheilkunde
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg-Süd
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg
city: Ostfildern
country: Germany
facility: Praxis für Neurologie und Psychiatrie
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus GmbH
city: Potsdam
country: Germany
facility: St.-Josefs-Krankenhaus
city: Potsdam
country: Germany
facility: Klinikum Ernst von Bergmann
city: Ravensburg
country: Germany
facility: Zentrum für Psychiatrie Weissenau
city: Recklinghausen
country: Germany
facility: Knappschafts-Krankenhaus
city: Rostock
country: Germany
facility: Universitätsklinikum
city: Rüdersdorf
country: Germany
facility: Evang.-Freichkirchl. Krankenhaus
city: Schorndorf
country: Germany
facility: Praxis für Neurologie
city: Schwedt/Oder
country: Germany
facility: Klinikum Uckermark GmbH
city: Schwerin
country: Germany
facility: HELIOS Kliniken Schwerin
city: Seesen
country: Germany
facility: Asklepios Kliniken Schildautal
city: Singen
country: Germany
facility: EMSA
city: Stadtroda
country: Germany
facility: Landesfachkrankenhaus für Psychatrie und Neurologie
city: Stralsund
country: Germany
facility: Praxis für Neurologie
city: Straubing
country: Germany
facility: Neurologische Praxis
city: Teupitz
country: Germany
facility: Landesklinik Teupitz
city: Tübingen
country: Germany
facility: Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung
city: Weiden
country: Germany
facility: Klinikum Weiden
city: Wiesbaden
country: Germany
facility: Stiftung Deutsche Klinik für Diagnostik
city: Wolfenbüttel
country: Germany
facility: Gemeinschaftspraxis für Neurologie
city: Wuppertal
country: Germany
facility: Klinikum Wuppertal
city: Würzburg
country: Germany
facility: Medizinisches Studienzentrum
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Zwickau
country: Germany
facility: Paracelsus Klinik
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
citation: 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):e001853. doi: 10.1136/bmjopen-2012-001853. Print 2013.
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-2011-000196.