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

Last updated: March 3, 2023
Sponsor: Ipsen
Overall Status: Completed

Phase

3

Condition

Dyskinesias

Neck Pain

Dystonia

Treatment

N/A

Clinical Study ID

NCT00447772
A-94-52120-098
2004-002086-20
  • Ages > 18
  • All Genders

Study 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

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

Exclusion Criteria:

  • Pre-treatment of cervical dystonia with botulinum toxin
  • Pre-treatment with botulinum toxin for any indication other than cervical dystoniawithin the past 12 months
  • Pure retro- or antecollis
  • Neurological or other diseases which may affect head and neck motor function orneuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy,motor neurone diseases, Bekhterev's disease

Study Design

Total Participants: 516
Study Start date:
October 01, 2004
Estimated Completion Date:
April 30, 2008

Connect with a study center

  • Krankenhaus der Barmherzigen Brüder

    Graz, A-8020
    Austria

    Site Not Available

  • NÖ LKH Grimmenstein-Hochegg

    Grimmenstein, A-2240
    Austria

    Site Not Available

  • NÖ LKH Grimmenstein-Hochegg

    Grimmenstein-Hochegg, A-2240
    Austria

    Site Not Available

  • Univ.-Klinik für Neurologie

    Innsbruck, A-6020
    Austria

    Site Not Available

  • Konventhospital der Barmherzigen Brüder

    Linz, A-4014
    Austria

    Site Not Available

  • O.Ö. Landes-Nervenklinik Wagner-Jauregg

    Linz, A-4020
    Austria

    Site Not Available

  • Neurolog. Klinik des RWTH Aachen

    Aachen, 52074
    Germany

    Site Not Available

  • Praxis für Anästhesiologie

    Ahaus, 48683
    Germany

    Site Not Available

  • Praxis für Neurologie und Psychiatrie

    Apolda, 99510
    Germany

    Site Not Available

  • Sächsisches Krankenhaus

    Arnsdorf, 01477
    Germany

    Site Not Available

  • Praxis für Neurologie

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Klinikum für Rehabilitation

    Bad Oeyenhausen, 32545
    Germany

    Site Not Available

  • Klinikum für Rehabilitation

    Bad Oeynhausen, 32545
    Germany

    Site Not Available

  • Praxis für Neurologie

    Bad Reichenhall, 83435
    Germany

    Site Not Available

  • Krankenhaus Hohe Warte

    Bayreuth, 95445
    Germany

    Site Not Available

  • Neurologische Rehabilitationsklinik

    Beelitz, 14547
    Germany

    Site Not Available

  • NRZ Neurologisches Rehabilitationszentrum Leipzig

    Bennewitz, 04828
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie

    Berlin, 14050
    Germany

    Site Not Available

  • Krankenhaus Henningsdorf

    Berlin,
    Germany

    Site Not Available

  • Neurologisches Facharztzentrum am St.-Gertrauden-KH

    Berlin, 10713
    Germany

    Site Not Available

  • Praxis für Neurologie

    Berlin, 10178
    Germany

    Site Not Available

  • Universitätsklinikum Charité, Campus Benjamin Franklin

    Berlin, 12200
    Germany

    Site Not Available

  • Universitätsklinikum Charité, Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • SALUS Fachkrankenhaus Bernburg

    Bernburg, 06406
    Germany

    Site Not Available

  • Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB

    Bielefeld, 33617
    Germany

    Site Not Available

  • Berufsg. Kliniken Bergmannsheil

    Bochum, 44789
    Germany

    Site Not Available

  • Praxis für Neurologie

    Bochum, 44787
    Germany

    Site Not Available

  • St.-Josef-Hospital

    Bochum, 44791
    Germany

    Site Not Available

  • Medizinische Einrichtung Rhein. F.-Wilhelms-Universität Bonn

    Bonn, 53105
    Germany

    Site Not Available

  • Zentralkrankenhaus Bremen-Ost

    Bremen, 28325
    Germany

    Site Not Available

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09131
    Germany

    Site Not Available

  • Praxis für Neurologie

    Dachau, 85221
    Germany

    Site Not Available

  • Bezirksklinikum Mainkofen

    Deggendorf, 94469
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307
    Germany

    Site Not Available

  • Malteser Krankenhaus St. Anna

    Duisburg, 47259
    Germany

    Site Not Available

  • University Hospital, Neurology Clinic

    Düsseldorf, 40225
    Germany

    Site Not Available

  • University Hospital, Neurology Clinic

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Landesklinik Eberswalde

    Eberswalde, 16225
    Germany

    Site Not Available

  • HELIOS Klinikum Erfurt

    Erfurt, 99089
    Germany

    Site Not Available

  • Uniklinik Erlangen

    Erlangen, 91054
    Germany

    Site Not Available

  • Alfried-Krupp-Krankenhaus

    Essen, 45117
    Germany

    Site Not Available

  • Universitätsklinik Essen

    Essen, 45147
    Germany

    Site Not Available

  • Kreiskrankenhaus Freiberg

    Freiberg, 09599
    Germany

    Site Not Available

  • Praxis für Neurologie und Psychiatrie

    Giessen, 35392
    Germany

    Site Not Available

  • Zentrum für Neurologie

    Giessen, 35385
    Germany

    Site Not Available

  • Praxis für Neurologie

    Gießen, 35390
    Germany

    Site Not Available

  • Praxis für Neurologie

    Gießen, 35390
    Germany

    Site Not Available

  • Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie

    Großschweidnitz, '02708
    Germany

    Site Not Available

  • Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie

    Großschweidnitz, '02708
    Germany

    Site Not Available

  • Bezirkskrankenhaus Günzburg

    Günzburg, 89312
    Germany

    Site Not Available

  • Bezirkskrankenhaus Günzburg

    Günzburg, 89312
    Germany

    Site Not Available

  • Katholisches Krankenhaus Hagen

    Hagen, 58099
    Germany

    Site Not Available

  • Klinikum Ambrock

    Hagen, 58091
    Germany

    Site Not Available

  • Städt. Krankenhaus Martha-Maria

    Halle, 06120
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie

    Hamburg, 20249
    Germany

    Site Not Available

  • Praxis für Neurologie

    Hamburg, 22525
    Germany

    Site Not Available

  • Neurologische Uniklinik

    Hannover,
    Germany

    Site Not Available

  • Praxis für Neurologie

    Hannover,
    Germany

    Site Not Available

  • Universitätskliniken des Saarlandes

    Homburg, 66421
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie/Psychiatrie

    Ilmenau, 98693
    Germany

    Site Not Available

  • Praxis für Neurologie

    Itzehoe, 25524
    Germany

    Site Not Available

  • Praxis für Neurologie

    Itzenhoe, 25524
    Germany

    Site Not Available

  • Uniklinik Jena

    Jena, 07743
    Germany

    Site Not Available

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655
    Germany

    Site Not Available

  • Universitätsklinikum Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Kath. Klinikum/Brüderkrankenhaus

    Koblenz, 56073
    Germany

    Site Not Available

  • Klinikum Koeln-Merheim

    Koeln,
    Germany

    Site Not Available

  • Neurologische Praxis

    Landshut, 84028
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie

    Leipzig, 04229
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie/Psychiatrie

    Leipzig, 04155
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Klinikum Lippe-Lemgo GmbH

    Lemgo, 32657
    Germany

    Site Not Available

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063
    Germany

    Site Not Available

  • Universitätsklinikum

    Lübeck, 23562
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie/Psychiatrie

    Lüneburg, 21335
    Germany

    Site Not Available

  • Universitätsklinikum

    Lübeck, 23562
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie/Psychiatrie

    Lüneburg, 21335
    Germany

    Site Not Available

  • Universitätsklinikum

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitätsklinikum

    Mainz, 55131
    Germany

    Site Not Available

  • Klinikum Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Praxis für Neurologie

    Mannheim, 68169
    Germany

    Site Not Available

  • Klinikum Minden

    Minden, 32427
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063
    Germany

    Site Not Available

  • Neurologisches Krankenhaus München

    München, 80804
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063
    Germany

    Site Not Available

  • Klinikum rechts der Isar

    München, 81675
    Germany

    Site Not Available

  • Neurologisches Krankenhaus München

    München, 80804
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Praxis für Neurologie und Nervenheilkunde

    Neubrandenburg, 17033
    Germany

    Site Not Available

  • Klinikum Nürnberg-Süd

    Nürnberg, 90471
    Germany

    Site Not Available

  • Klinikum Nürnberg-Süd

    Nürnberg, 90471
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Oldenburg

    Oldenburg, 26122
    Germany

    Site Not Available

  • Praxis für Neurologie und Psychiatrie

    Ostfildern, 73760
    Germany

    Site Not Available

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, 33098
    Germany

    Site Not Available

  • Klinikum Ernst von Bergmann

    Potsdam, 14467
    Germany

    Site Not Available

  • St.-Josefs-Krankenhaus

    Potsdam, 11471
    Germany

    Site Not Available

  • Zentrum für Psychiatrie Weissenau

    Ravensburg, 88214
    Germany

    Site Not Available

  • Knappschafts-Krankenhaus

    Recklinghausen, 45657
    Germany

    Site Not Available

  • Universitätsklinikum

    Rostock, 18147
    Germany

    Site Not Available

  • Evang.-Freichkirchl. Krankenhaus

    Rüdersdorf, 15562
    Germany

    Site Not Available

  • Evang.-Freichkirchl. Krankenhaus

    Rüdersdorf, 15562
    Germany

    Site Not Available

  • Praxis für Neurologie

    Schorndorf, 73614
    Germany

    Site Not Available

  • Klinikum Uckermark GmbH

    Schwedt/Oder, 16303
    Germany

    Site Not Available

  • HELIOS Kliniken Schwerin

    Schwerin, 19055
    Germany

    Site Not Available

  • Asklepios Kliniken Schildautal

    Seesen, 38723
    Germany

    Site Not Available

  • EMSA

    Singen, 78224
    Germany

    Site Not Available

  • Landesfachkrankenhaus für Psychatrie und Neurologie

    Stadtroda, 07646
    Germany

    Site Not Available

  • Praxis für Neurologie

    Stralsund, 18439
    Germany

    Site Not Available

  • Neurologische Praxis

    Straubing, 94315
    Germany

    Site Not Available

  • Landesklinik Teupitz

    Teupitz, 15775
    Germany

    Site Not Available

  • Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung

    Tübingen, 72076
    Germany

    Site Not Available

  • Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung

    Tübingen, 72076
    Germany

    Site Not Available

  • Klinikum Weiden

    Weiden, 92637
    Germany

    Site Not Available

  • Stiftung Deutsche Klinik für Diagnostik

    Wiesbaden, 65191
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie

    Wolfenbüttel, 38300
    Germany

    Site Not Available

  • Gemeinschaftspraxis für Neurologie

    Wolfenbüttel, 38300
    Germany

    Site Not Available

  • Klinikum Wuppertal

    Wuppertal, 42283
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, 97070
    Germany

    Site Not Available

  • Medizinisches Studienzentrum

    Würzburg, 97070
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg

    Würzburg, 97070
    Germany

    Site Not Available

  • Paracelsus Klinik

    Zwickau, 08060
    Germany

    Site Not Available

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