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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447772
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : July 24, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Drug: Botulinum type A toxin (Dysport®) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Multicentre Study to Demonstrate the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia
Study Start Date : October 2004
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
Experimental: 1 Drug: Botulinum type A toxin (Dysport®)
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia

Primary Outcome Measures :
  1. Change in Tsui score [ Time Frame: Week 4 versus baseline in week 0 ]

Secondary Outcome Measures :
  1. Recording of quality of life (disease specific quality of life questionnaire) [ Time Frame: Week 0, 4, 12 ]
  2. Evaluation of efficacy and safety/tolerability by investigator and patient [ Time Frame: Week 4, 12 ]
  3. Documentation of the dose and of the injection protocol for any subsequent injections [ Time Frame: Week 12 ]
  4. Descriptive analysis of subgroups [ Time Frame: Week 0, 4, 12 ]
  5. Tsui score profile (while patient is sitting) [ Time Frame: Week 0, 4, 12 ]
  6. Optional: additional determination of Tsui score (while patient is walking) [ Time Frame: Week 0, 4, 12 ]
  7. Comparison of Tsui scores with patient sitting and patient walking [ Time Frame: Week 0, 4, 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447772

  Hide Study Locations
Krankenhaus der Barmherzigen Brüder
Graz, Austria, A-8020
NÖ LKH Grimmenstein-Hochegg
Grimmenstein-Hochegg, Austria, A-2240
Univ.-Klinik für Neurologie
Innsbruck, Austria, A-6020
Konventhospital der Barmherzigen Brüder
Linz, Austria, A-4014
O.Ö. Landes-Nervenklinik Wagner-Jauregg
Linz, Austria, A-4020
Neurolog. Klinik des RWTH Aachen
Aachen, Germany, 52074
Praxis für Anästhesiologie
Ahaus, Germany, 48683
Praxis für Neurologie und Psychiatrie
Apolda, Germany, 99510
Sächsisches Krankenhaus
Arnsdorf, Germany, 01477
Praxis für Neurologie
Aschaffenburg, Germany, 63739
Klinikum für Rehabilitation
Bad Oeyenhausen, Germany, 32545
Praxis für Neurologie
Bad Reichenhall, Germany, 83435
Krankenhaus Hohe Warte
Bayreuth, Germany, 95445
Neurologische Rehabilitationsklinik
Beelitz, Germany, 14547
NRZ Neurologisches Rehabilitationszentrum Leipzig
Bennewitz, Germany, 04828
Praxis für Neurologie
Berlin, Germany, 10178
Neurologisches Facharztzentrum am St.-Gertrauden-KH
Berlin, Germany, 10713
Praxis für Neurologie
Berlin, Germany, 10719
Universitätsklinikum Charité, Campus Benjamin Franklin
Berlin, Germany, 12200
Universitätsklinikum Charité, Campus Virchow-Klinikum
Berlin, Germany, 13353
Gemeinschaftspraxis für Neurologie
Berlin, Germany, 14050
Krankenhaus Henningsdorf
Berlin, Germany
SALUS Fachkrankenhaus Bernburg
Bernburg, Germany, 06406
Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB
Bielefeld, Germany, 33617
Praxis für Neurologie
Bochum, Germany, 44787
Berufsg. Kliniken Bergmannsheil
Bochum, Germany, 44789
Bochum, Germany, 44791
Medizinische Einrichtung Rhein. F.-Wilhelms-Universität Bonn
Bonn, Germany, 53105
Zentralkrankenhaus Bremen-Ost
Bremen, Germany, 28325
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09131
Praxis für Neurologie
Dachau, Germany, 85221
Bezirksklinikum Mainkofen
Deggendorf, Germany, 94469
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Malteser Krankenhaus St. Anna
Duisburg, Germany, 47259
University Hospital, Neurology Clinic
Düsseldorf, Germany, 40225
Landesklinik Eberswalde
Eberswalde, Germany, 16225
HELIOS Klinikum Erfurt
Erfurt, Germany, 99089
Uniklinik Erlangen
Erlangen, Germany, 91054
Essen, Germany, 45117
Universitätsklinik Essen
Essen, Germany, 45147
Kreiskrankenhaus Freiberg
Freiberg, Germany, 09599
Zentrum für Neurologie
Giessen, Germany, 35385
Praxis für Neurologie und Psychiatrie
Giessen, Germany, 35392
Praxis für Neurologie
Gießen, Germany, 35390
Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie
Großschweidnitz, Germany, '02708
Bezirkskrankenhaus Günzburg
Günzburg, Germany, 89312
Klinikum Ambrock
Hagen, Germany, 58091
Katholisches Krankenhaus Hagen
Hagen, Germany, 58099
Städt. Krankenhaus Martha-Maria
Halle, Germany, 06120
Gemeinschaftspraxis für Neurologie
Hamburg, Germany, 20249
Praxis für Neurologie
Hamburg, Germany, 22525
Neurologische Uniklinik
Hannover, Germany
Praxis für Neurologie
Hannover, Germany
Universitätskliniken des Saarlandes
Homburg, Germany, 66421
Gemeinschaftspraxis für Neurologie/Psychiatrie
Ilmenau, Germany, 98693
Praxis für Neurologie
Itzenhoe, Germany, 25524
Uniklinik Jena
Jena, Germany, 07743
Westpfalz-Klinikum GmbH
Kaiserslautern, Germany, 67655
Universitätsklinikum Kiel
Kiel, Germany, 24105
Kath. Klinikum/Brüderkrankenhaus
Koblenz, Germany, 56073
Klinikum Koeln-Merheim
Koeln, Germany
Neurologische Praxis
Landshut, Germany, 84028
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Gemeinschaftspraxis für Neurologie/Psychiatrie
Leipzig, Germany, 04155
Gemeinschaftspraxis für Neurologie
Leipzig, Germany, 04229
Klinikum Lippe-Lemgo GmbH
Lemgo, Germany, 32657
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, 67063
Lübeck, Germany, 23562
Gemeinschaftspraxis für Neurologie/Psychiatrie
Lüneburg, Germany, 21335
Magdeburg, Germany, 39120
Mainz, Germany, 55131
Klinikum Mannheim
Mannheim, Germany, 68167
Praxis für Neurologie
Mannheim, Germany, 68169
Klinikum Minden
Minden, Germany, 32427
Kliniken Maria Hilf GmbH
Mönchengladbach, Germany, 41063
Neurologisches Krankenhaus München
München, Germany, 80804
Klinikum rechts der Isar
München, Germany, 81675
Universitätsklinikum Münster
Münster, Germany, 48149
Praxis für Neurologie und Nervenheilkunde
Neubrandenburg, Germany, 17033
Klinikum Nürnberg-Süd
Nürnberg, Germany, 90471
Evangelisches Krankenhaus Oldenburg
Oldenburg, Germany, 26122
Praxis für Neurologie und Psychiatrie
Ostfildern, Germany, 73760
St. Vincenz-Krankenhaus GmbH
Paderborn, Germany, 33098
Potsdam, Germany, 11471
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
Zentrum für Psychiatrie Weissenau
Ravensburg, Germany, 88214
Recklinghausen, Germany, 45657
Rostock, Germany, 18147
Evang.-Freichkirchl. Krankenhaus
Rüdersdorf, Germany, 15562
Praxis für Neurologie
Schorndorf, Germany, 73614
Klinikum Uckermark GmbH
Schwedt/Oder, Germany, 16303
HELIOS Kliniken Schwerin
Schwerin, Germany, 19055
Asklepios Kliniken Schildautal
Seesen, Germany, 38723
Singen, Germany, 78224
Landesfachkrankenhaus für Psychatrie und Neurologie
Stadtroda, Germany, 07646
Praxis für Neurologie
Stralsund, Germany, 18439
Neurologische Praxis
Straubing, Germany, 94315
Landesklinik Teupitz
Teupitz, Germany, 15775
Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung
Tübingen, Germany, 72076
Klinikum Weiden
Weiden, Germany, 92637
Stiftung Deutsche Klinik für Diagnostik
Wiesbaden, Germany, 65191
Gemeinschaftspraxis für Neurologie
Wolfenbüttel, Germany, 38300
Klinikum Wuppertal
Wuppertal, Germany, 42283
Medizinisches Studienzentrum
Würzburg, Germany, 97070
Universitätsklinikum Würzburg
Würzburg, Germany, 97070
Paracelsus Klinik
Zwickau, Germany, 08060
Sponsors and Collaborators
Study Director: Bert Van Eijk, MD Ipsen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bert Van Eijk, Ipsen Identifier: NCT00447772     History of Changes
Other Study ID Numbers: A-94-52120-098
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Ipsen:
Dysport, Cervical Dystonia

Additional relevant MeSH terms:
Dystonic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents