Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
NCT ID: NCT00447772
Last Updated: 2023-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
516 participants
INTERVENTIONAL
2004-10-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Botulinum toxin type A
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Interventions
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Botulinum toxin type A
Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Outpatient
* Patients to be of age 18 years or older
* Written informed consent to participate in the study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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, , Austria
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
Praxis für Neurologie
Berlin, , Germany
Neurologisches Facharztzentrum am St.-Gertrauden-KH
Berlin, , Germany
Praxis für Neurologie
Berlin, , Germany
Universitätsklinikum Charité, Campus Benjamin Franklin
Berlin, , Germany
Universitätsklinikum Charité, Campus Virchow-Klinikum
Berlin, , Germany
Gemeinschaftspraxis für Neurologie
Berlin, , Germany
Krankenhaus Henningsdorf
Berlin, , Germany
SALUS Fachkrankenhaus Bernburg
Bernburg, , Germany
Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB
Bielefeld, , Germany
Praxis für Neurologie
Bochum, , Germany
Berufsg. Kliniken Bergmannsheil
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
Klinikum Koeln-Merheim
Cologne, , 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
Zentrum für Neurologie
Giessen, , Germany
Praxis für Neurologie
Giessen, , Germany
Praxis für Neurologie und Psychiatrie
Giessen, , Germany
Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie
Großschweidnitz, , Germany
Bezirkskrankenhaus Günzburg
Günzburg, , Germany
Klinikum Ambrock
Hagen, , Germany
Katholisches Krankenhaus Hagen
Hagen, , Germany
Städt. Krankenhaus Martha-Maria
Halle, , Germany
Gemeinschaftspraxis für Neurologie
Hamburg, , Germany
Praxis für Neurologie
Hamburg, , Germany
Neurologische Uniklinik
Hanover, , Germany
Praxis für Neurologie
Hanover, , 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
Neurologische Praxis
Landshut, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Gemeinschaftspraxis für Neurologie/Psychiatrie
Leipzig, , Germany
Gemeinschaftspraxis für Neurologie
Leipzig, , Germany
Klinikum Lippe-Lemgo GmbH
Lemgo, , Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, , Germany
Universitätsklinikum
Lübeck, , 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
Neurologisches Krankenhaus München
München, , Germany
Klinikum rechts der Isar
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Praxis für Neurologie und Nervenheilkunde
Neubrandenburg, , Germany
Klinikum Nürnberg-Süd
Nuremberg, , Germany
Evangelisches Krankenhaus Oldenburg
Oldenburg, , Germany
Praxis für Neurologie und Psychiatrie
Ostfildern, , Germany
St. Vincenz-Krankenhaus GmbH
Paderborn, , Germany
St.-Josefs-Krankenhaus
Potsdam, , Germany
Klinikum Ernst von Bergmann
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, , 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, , Germany
Countries
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References
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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.
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.
Other Identifiers
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2004-002086-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A-94-52120-098
Identifier Type: -
Identifier Source: org_study_id
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