Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
Multicentre Open Study on the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia
2 other identifiers
interventional
516
2 countries
106
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2004
Typical duration for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 13, 2007
CompletedFirst Posted
Study publicly available on registry
March 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
July 30, 2018
CompletedMarch 30, 2023
March 1, 2023
3.3 years
March 13, 2007
May 9, 2017
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
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
- +3 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Eligibility Criteria
You may qualify if:
- De novo patients with cervical dystonia
- Outpatient
- Patients to be of age 18 years or older
- Written informed consent to participate in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (106)
Krankenhaus der Barmherzigen Brüder
Graz, A-8020, Austria
NÖ LKH Grimmenstein-Hochegg
Grimmenstein, A-2240, Austria
Univ.-Klinik für Neurologie
Innsbruck, A-6020, Austria
Konventhospital der Barmherzigen Brüder
Linz, A-4014, Austria
O.Ö. Landes-Nervenklinik Wagner-Jauregg
Linz, A-4020, Austria
Neurolog. Klinik des RWTH Aachen
Aachen, 52074, Germany
Praxis für Anästhesiologie
Ahaus, 48683, Germany
Praxis für Neurologie und Psychiatrie
Apolda, 99510, Germany
Sächsisches Krankenhaus
Arnsdorf, 01477, Germany
Praxis für Neurologie
Aschaffenburg, 63739, Germany
Klinikum für Rehabilitation
Bad Oeynhausen, 32545, Germany
Praxis für Neurologie
Bad Reichenhall, 83435, Germany
Krankenhaus Hohe Warte
Bayreuth, 95445, Germany
Neurologische Rehabilitationsklinik
Beelitz, 14547, Germany
NRZ Neurologisches Rehabilitationszentrum Leipzig
Bennewitz, 04828, Germany
Praxis für Neurologie
Berlin, 10178, Germany
Neurologisches Facharztzentrum am St.-Gertrauden-KH
Berlin, 10713, Germany
Praxis für Neurologie
Berlin, 10719, Germany
Universitätsklinikum Charité, Campus Benjamin Franklin
Berlin, 12200, Germany
Universitätsklinikum Charité, Campus Virchow-Klinikum
Berlin, 13353, Germany
Gemeinschaftspraxis für Neurologie
Berlin, 14050, Germany
Krankenhaus Henningsdorf
Berlin, Germany
SALUS Fachkrankenhaus Bernburg
Bernburg, 06406, Germany
Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB
Bielefeld, 33617, Germany
Praxis für Neurologie
Bochum, 44787, Germany
Berufsg. Kliniken Bergmannsheil
Bochum, 44789, Germany
St.-Josef-Hospital
Bochum, 44791, Germany
Medizinische Einrichtung Rhein. F.-Wilhelms-Universität Bonn
Bonn, 53105, Germany
Zentralkrankenhaus Bremen-Ost
Bremen, 28325, Germany
Klinikum Chemnitz gGmbH
Chemnitz, 09131, Germany
Klinikum Koeln-Merheim
Cologne, Germany
Praxis für Neurologie
Dachau, 85221, Germany
Bezirksklinikum Mainkofen
Deggendorf, 94469, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Malteser Krankenhaus St. Anna
Duisburg, 47259, Germany
University Hospital, Neurology Clinic
Düsseldorf, 40225, Germany
Landesklinik Eberswalde
Eberswalde, 16225, Germany
HELIOS Klinikum Erfurt
Erfurt, 99089, Germany
Uniklinik Erlangen
Erlangen, 91054, Germany
Alfried-Krupp-Krankenhaus
Essen, 45117, Germany
Universitätsklinik Essen
Essen, 45147, Germany
Kreiskrankenhaus Freiberg
Freiberg, 09599, Germany
Zentrum für Neurologie
Giessen, 35385, Germany
Praxis für Neurologie
Giessen, 35390, Germany
Praxis für Neurologie und Psychiatrie
Giessen, 35392, Germany
Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie
Großschweidnitz, '02708, Germany
Bezirkskrankenhaus Günzburg
Günzburg, 89312, Germany
Klinikum Ambrock
Hagen, 58091, Germany
Katholisches Krankenhaus Hagen
Hagen, 58099, Germany
Städt. Krankenhaus Martha-Maria
Halle, 06120, Germany
Gemeinschaftspraxis für Neurologie
Hamburg, 20249, Germany
Praxis für Neurologie
Hamburg, 22525, Germany
Neurologische Uniklinik
Hanover, Germany
Praxis für Neurologie
Hanover, Germany
Universitätskliniken des Saarlandes
Homburg, 66421, Germany
Gemeinschaftspraxis für Neurologie/Psychiatrie
Ilmenau, 98693, Germany
Praxis für Neurologie
Itzehoe, 25524, Germany
Uniklinik Jena
Jena, 07743, Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, 67655, Germany
Universitätsklinikum Kiel
Kiel, 24105, Germany
Kath. Klinikum/Brüderkrankenhaus
Koblenz, 56073, Germany
Neurologische Praxis
Landshut, 84028, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Gemeinschaftspraxis für Neurologie/Psychiatrie
Leipzig, 04155, Germany
Gemeinschaftspraxis für Neurologie
Leipzig, 04229, Germany
Klinikum Lippe-Lemgo GmbH
Lemgo, 32657, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, 67063, Germany
Universitätsklinikum
Lübeck, 23562, Germany
Gemeinschaftspraxis für Neurologie/Psychiatrie
Lüneburg, 21335, Germany
Universitätsklinikum
Magdeburg, 39120, Germany
Universitätsklinikum
Mainz, 55131, Germany
Klinikum Mannheim
Mannheim, 68167, Germany
Praxis für Neurologie
Mannheim, 68169, Germany
Klinikum Minden
Minden, 32427, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063, Germany
Neurologisches Krankenhaus München
München, 80804, Germany
Klinikum rechts der Isar
München, 81675, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Praxis für Neurologie und Nervenheilkunde
Neubrandenburg, 17033, Germany
Klinikum Nürnberg-Süd
Nuremberg, 90471, Germany
Evangelisches Krankenhaus Oldenburg
Oldenburg, 26122, Germany
Praxis für Neurologie und Psychiatrie
Ostfildern, 73760, Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098, Germany
St.-Josefs-Krankenhaus
Potsdam, 11471, Germany
Klinikum Ernst von Bergmann
Potsdam, 14467, Germany
Zentrum für Psychiatrie Weissenau
Ravensburg, 88214, Germany
Knappschafts-Krankenhaus
Recklinghausen, 45657, Germany
Universitätsklinikum
Rostock, 18147, Germany
Evang.-Freichkirchl. Krankenhaus
Rüdersdorf, 15562, Germany
Praxis für Neurologie
Schorndorf, 73614, Germany
Klinikum Uckermark GmbH
Schwedt, 16303, Germany
HELIOS Kliniken Schwerin
Schwerin, 19055, Germany
Asklepios Kliniken Schildautal
Seesen, 38723, Germany
EMSA
Singen, 78224, Germany
Landesfachkrankenhaus für Psychatrie und Neurologie
Stadtroda, 07646, Germany
Praxis für Neurologie
Stralsund, 18439, Germany
Neurologische Praxis
Straubing, 94315, Germany
Landesklinik Teupitz
Teupitz, 15775, Germany
Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung
Tübingen, 72076, Germany
Klinikum Weiden
Weiden, 92637, Germany
Stiftung Deutsche Klinik für Diagnostik
Wiesbaden, 65191, Germany
Gemeinschaftspraxis für Neurologie
Wolfenbüttel, 38300, Germany
Klinikum Wuppertal
Wuppertal, 42283, Germany
Medizinisches Studienzentrum
Würzburg, 97070, Germany
Universitätsklinikum Würzburg
Würzburg, 97070, Germany
Paracelsus Klinik
Zwickau, 08060, Germany
Related 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):e001853. doi: 10.1136/bmjopen-2012-001853. Print 2013.
PMID: 23604344RESULTHefter 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.
PMID: 22021883RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director, Neurology
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2007
First Posted
March 15, 2007
Study Start
October 1, 2004
Primary Completion
February 1, 2008
Study Completion
April 1, 2008
Last Updated
March 30, 2023
Results First Posted
July 30, 2018
Record last verified: 2023-03