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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00447772
First received: March 13, 2007
Last updated: July 23, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Cervical Dystonia
Drug: Botulinum type A toxin (Dysport®)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Change in Tsui score [ Time Frame: Week 4 versus baseline in week 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recording of quality of life (disease specific quality of life questionnaire) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Evaluation of efficacy and safety/tolerability by investigator and patient [ Time Frame: Week 4, 12 ] [ Designated as safety issue: Yes ]
  • Documentation of the dose and of the injection protocol for any subsequent injections [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Descriptive analysis of subgroups [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Tsui score profile (while patient is sitting) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Optional: additional determination of Tsui score (while patient is walking) [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]
  • Comparison of Tsui scores with patient sitting and patient walking [ Time Frame: Week 0, 4, 12 ] [ Designated as safety issue: No ]

Enrollment: 516
Study Start Date: October 2004
Study Completion Date: April 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447772

  Hide Study Locations
Locations
Austria
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
O.Ö. Landes-Nervenklinik Wagner-Jauregg
Linz, Austria, A-4020
Konventhospital der Barmherzigen Brüder
Linz, Austria, A-4014
Germany
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, 10719
Neurologisches Facharztzentrum am St.-Gertrauden-KH
Berlin, Germany, 10713
Praxis für Neurologie
Berlin, Germany, 10178
Gemeinschaftspraxis für Neurologie
Berlin, Germany, 14050
Universitätsklinikum Charité, Campus Benjamin Franklin
Berlin, Germany, 12200
Krankenhaus Henningsdorf
Berlin, Germany
Universitätsklinikum Charité, Campus Virchow-Klinikum
Berlin, Germany, 13353
SALUS Fachkrankenhaus Bernburg
Bernburg, Germany, 06406
Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB
Bielefeld, Germany, 33617
St.-Josef-Hospital
Bochum, Germany, 44791
Berufsg. Kliniken Bergmannsheil
Bochum, Germany, 44789
Praxis für Neurologie
Bochum, Germany, 44787
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
Alfried-Krupp-Krankenhaus
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
Katholisches Krankenhaus Hagen
Hagen, Germany, 58099
Klinikum Ambrock
Hagen, Germany, 58091
Städt. Krankenhaus Martha-Maria
Halle, Germany, 06120
Praxis für Neurologie
Hamburg, Germany, 22525
Gemeinschaftspraxis für Neurologie
Hamburg, Germany, 20249
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
Gemeinschaftspraxis für Neurologie
Leipzig, Germany, 04229
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Gemeinschaftspraxis für Neurologie/Psychiatrie
Leipzig, Germany, 04155
Klinikum Lippe-Lemgo GmbH
Lemgo, Germany, 32657
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, 67063
Universitätsklinikum
Lübeck, Germany, 23562
Gemeinschaftspraxis für Neurologie/Psychiatrie
Lüneburg, Germany, 21335
Universitätsklinikum
Magdeburg, Germany, 39120
Universitätsklinikum
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
Klinikum rechts der Isar
München, Germany, 81675
Neurologisches Krankenhaus München
München, Germany, 80804
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
Klinikum Ernst von Bergmann
Potsdam, Germany, 14467
St.-Josefs-Krankenhaus
Potsdam, Germany, 11471
Zentrum für Psychiatrie Weissenau
Ravensburg, Germany, 88214
Knappschafts-Krankenhaus
Recklinghausen, Germany, 45657
Universitätsklinikum
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
EMSA
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
Universitätsklinikum Würzburg
Würzburg, Germany, 97070
Medizinisches Studienzentrum
Würzburg, Germany, 97070
Paracelsus Klinik
Zwickau, Germany, 08060
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Bert Van Eijk, MD Ipsen
  More Information

No publications provided by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bert Van Eijk, Ipsen
ClinicalTrials.gov Identifier: NCT00447772     History of Changes
Other Study ID Numbers: A-94-52120-098
Study First Received: March 13, 2007
Last Updated: July 23, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety

Keywords provided by Ipsen:
Dysport, Cervical Dystonia

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014