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Cervical DystoniaPhase 3NCT00447772

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

A Phase 3 study testing Botulinum toxin type A in people with Cervical Dystonia, run by Ipsen at 106 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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®. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Dystonia
What is being tested?
Botulinum toxin type A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
106 sitesin 2 countries
Study dates
Oct 2004to Apr 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • De novo patients with cervical dystonia
  • Outpatient
  • Patients to be of age 18 years or older
  • Written informed consent to participate in the study

Who cannot join

  • 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

Trial locations and contacts

106 sites in 2 countries.

106 sites in 2 countries

Germany101 sites

  • Neurolog. Klinik des RWTH Aachen

    Aachen, 52074

  • Praxis für Anästhesiologie

    Ahaus, 48683

  • Praxis für Neurologie und Psychiatrie

    Apolda, 99510

  • Sächsisches Krankenhaus

    Arnsdorf, 01477

  • Praxis für Neurologie

    Aschaffenburg, 63739

  • Klinikum für Rehabilitation

    Bad Oeynhausen, 32545

  • Praxis für Neurologie

    Bad Reichenhall, 83435

  • Krankenhaus Hohe Warte

    Bayreuth, 95445

  • Neurologische Rehabilitationsklinik

    Beelitz, 14547

  • NRZ Neurologisches Rehabilitationszentrum Leipzig

    Bennewitz, 04828

  • Praxis für Neurologie

    Berlin, 10178

  • Neurologisches Facharztzentrum am St.-Gertrauden-KH

    Berlin, 10713

  • Praxis für Neurologie

    Berlin, 10719

  • Universitätsklinikum Charité, Campus Benjamin Franklin

    Berlin, 12200

  • Universitätsklinikum Charité, Campus Virchow-Klinikum

    Berlin, 13353

  • Gemeinschaftspraxis für Neurologie

    Berlin, 14050

  • Krankenhaus Henningsdorf

    Berlin

  • SALUS Fachkrankenhaus Bernburg

    Bernburg, 06406

  • Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB

    Bielefeld, 33617

  • Praxis für Neurologie

    Bochum, 44787

  • Berufsg. Kliniken Bergmannsheil

    Bochum, 44789

  • St.-Josef-Hospital

    Bochum, 44791

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

    Bonn, 53105

  • Zentralkrankenhaus Bremen-Ost

    Bremen, 28325

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09131

  • Klinikum Koeln-Merheim

    Cologne

  • Praxis für Neurologie

    Dachau, 85221

  • Bezirksklinikum Mainkofen

    Deggendorf, 94469

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Malteser Krankenhaus St. Anna

    Duisburg, 47259

  • University Hospital, Neurology Clinic

    Düsseldorf, 40225

  • Landesklinik Eberswalde

    Eberswalde, 16225

  • HELIOS Klinikum Erfurt

    Erfurt, 99089

  • Uniklinik Erlangen

    Erlangen, 91054

  • Alfried-Krupp-Krankenhaus

    Essen, 45117

  • Universitätsklinik Essen

    Essen, 45147

  • Kreiskrankenhaus Freiberg

    Freiberg, 09599

  • Zentrum für Neurologie

    Giessen, 35385

  • Praxis für Neurologie

    Giessen, 35390

  • Praxis für Neurologie und Psychiatrie

    Giessen, 35392

  • Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie

    Großschweidnitz, '02708

  • Bezirkskrankenhaus Günzburg

    Günzburg, 89312

  • Klinikum Ambrock

    Hagen, 58091

  • Katholisches Krankenhaus Hagen

    Hagen, 58099

  • Städt. Krankenhaus Martha-Maria

    Halle, 06120

  • Gemeinschaftspraxis für Neurologie

    Hamburg, 20249

  • Praxis für Neurologie

    Hamburg, 22525

  • Neurologische Uniklinik

    Hanover

  • Praxis für Neurologie

    Hanover

  • Universitätskliniken des Saarlandes

    Homburg, 66421

  • Gemeinschaftspraxis für Neurologie/Psychiatrie

    Ilmenau, 98693

  • Praxis für Neurologie

    Itzehoe, 25524

  • Uniklinik Jena

    Jena, 07743

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655

  • Universitätsklinikum Kiel

    Kiel, 24105

  • Kath. Klinikum/Brüderkrankenhaus

    Koblenz, 56073

  • Neurologische Praxis

    Landshut, 84028

  • Universitätsklinikum Leipzig

    Leipzig, 04103

  • Gemeinschaftspraxis für Neurologie/Psychiatrie

    Leipzig, 04155

  • Gemeinschaftspraxis für Neurologie

    Leipzig, 04229

  • Klinikum Lippe-Lemgo GmbH

    Lemgo, 32657

  • Universitätsklinikum

    Lübeck, 23562

  • Klinikum der Stadt Ludwigshafen

    Ludwigshafen, 67063

  • Gemeinschaftspraxis für Neurologie/Psychiatrie

    Lüneburg, 21335

  • Universitätsklinikum

    Magdeburg, 39120

  • Universitätsklinikum

    Mainz, 55131

  • Klinikum Mannheim

    Mannheim, 68167

  • Praxis für Neurologie

    Mannheim, 68169

  • Klinikum Minden

    Minden, 32427

  • Kliniken Maria Hilf GmbH

    Mönchengladbach, 41063

  • Neurologisches Krankenhaus München

    München, 80804

  • Klinikum rechts der Isar

    München, 81675

  • Universitätsklinikum Münster

    Münster, 48149

  • Praxis für Neurologie und Nervenheilkunde

    Neubrandenburg, 17033

  • Klinikum Nürnberg-Süd

    Nuremberg, 90471

  • Evangelisches Krankenhaus Oldenburg

    Oldenburg, 26122

  • Praxis für Neurologie und Psychiatrie

    Ostfildern, 73760

  • St. Vincenz-Krankenhaus GmbH

    Paderborn, 33098

  • St.-Josefs-Krankenhaus

    Potsdam, 11471

  • Klinikum Ernst von Bergmann

    Potsdam, 14467

  • Zentrum für Psychiatrie Weissenau

    Ravensburg, 88214

  • Knappschafts-Krankenhaus

    Recklinghausen, 45657

  • Universitätsklinikum

    Rostock, 18147

  • Evang.-Freichkirchl. Krankenhaus

    Rüdersdorf, 15562

  • Praxis für Neurologie

    Schorndorf, 73614

  • Klinikum Uckermark GmbH

    Schwedt, 16303

  • HELIOS Kliniken Schwerin

    Schwerin, 19055

  • Asklepios Kliniken Schildautal

    Seesen, 38723

  • EMSA

    Singen, 78224

  • Landesfachkrankenhaus für Psychatrie und Neurologie

    Stadtroda, 07646

  • Praxis für Neurologie

    Stralsund, 18439

  • Neurologische Praxis

    Straubing, 94315

  • Landesklinik Teupitz

    Teupitz, 15775

  • Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung

    Tübingen, 72076

  • Klinikum Weiden

    Weiden, 92637

  • Stiftung Deutsche Klinik für Diagnostik

    Wiesbaden, 65191

  • Gemeinschaftspraxis für Neurologie

    Wolfenbüttel, 38300

  • Klinikum Wuppertal

    Wuppertal, 42283

  • Medizinisches Studienzentrum

    Würzburg, 97070

  • Universitätsklinikum Würzburg

    Würzburg, 97070

  • Paracelsus Klinik

    Zwickau, 08060

Other trials in Germany

Austria5 sites

  • Krankenhaus der Barmherzigen Brüder

    Graz, A-8020

  • NÖ LKH Grimmenstein-Hochegg

    Grimmenstein, A-2240

  • Univ.-Klinik für Neurologie

    Innsbruck, A-6020

  • Konventhospital der Barmherzigen Brüder

    Linz, A-4014

  • O.Ö. Landes-Nervenklinik Wagner-Jauregg

    Linz, A-4020

Other trials in Austria

About this study

Official title: Multicentre Open Study on the Efficacy and Safety of Botulinum Toxin A (500 Units Dysport®) in the Treatment of Heterogeneous Forms of Cervical Dystonia

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.

Keywords
Dysport, Cervical Dystonia
Medical subject headings
Torticollis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type ABiological

    Also called AbobotulinumtoxinA (Dysport®)

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

Study groups in NCT00447772
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Biological: Botulinum toxin type A

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 4 or Week 12 (up to 12 weeks)

Secondary outcomes (8)

  1. Change in the Total Score of the Tsui Rating Scale (Patient in Sitting Position) Between Visit 1 (Week 0) and Visit 3 (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 Week 12 visit is presented.

    Measured: Baseline to Week 12

  2. 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)

    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 changes in the total score of the Tsui rating scale (patient walking) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

    Measured: Baseline to Week 4 and Week 12

  3. 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)

    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).

    A higher score for each subscale represents severe CD symptoms. 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 changes in the subscores A to D of the Tsui rating scale (patient in the sitting position) between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

    Measured: Baseline to Week 4 and Week 12

  4. 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)

    The CDQ-24 is a disease-specific quality of life (QoL) instrument and was assessed at Visits 1 to 3. It consists of 24 items investigating problems in daily living skills related to CD.

    This instrument is based on 5 subscales: Stigma, Emotional well-being, Pain, Activities of daily living (ADL), Social/family life to which a number of the 24 items are assigned. There are five possible answers to each item representing increasing severity of impairment (scores 0 to 4). The total scores ranged from 0 to 96 (best to worst QoL). In order to obtain scores of the individual subscales, the total score of each subscale (sum of the individual item scores) was transformed linearly to a 0 to 100 scale (best to worst QoL).

    The mean changes in the CDQ-24 total score between baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

    Measured: Baseline to Week 4 and Week 12

  5. 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)

    The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).

    The mean changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented.

    Measured: Baseline to Week 4 and Week 12

  6. Categorical 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)

    The weekly recorded patient diary consists of the three items: Day-to-Day Capacities and Activities, Pain and Duration of Pain. Each item was rated by the patient on an 11-point scale ranging from 0 = no problems at all to 10 = most severe problems (the actual wording is adapted to each item in question).

    The following categorical changes between the baseline (Week 0 visit) and the Week 4 and Week 12 visits are presented: Improvement, No change and Deterioration.

    Measured: Baseline to Week 4 and Week 12

  7. Number of Patients Without Pain and/or With a Reduction in Pain Based on a Global Assessment of Pain by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)

    Global pain was assessed at Visit 2 (Week 4) and Visit 3 (Week 12); investigators and patients assessed change in global pain according to the following response categories:

    1. = no pain (anymore)
    2. = less pain
    3. = no change
    4. = more pain

    The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.

    Measured: Week 4 visit and Week 12 visit

  8. Global Assessment of Efficacy by the Investigator and by the Patient at Visit 2 (Week 4) and Visit 3 (Week 12)

    At Visit 2 (Week 4) and Visit 3 (Week 12) investigators and patients assessed global efficacy of injection of 500 U Dysport® according to the following response categories:

    1. = very good
    2. = good
    3. = moderate
    4. = insufficient

    The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented.

    Measured: Week 4 and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2007 (estimated)
  2. Study startOct 2004
  3. Primary completionFeb 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00447772
Sponsor's protocol ID
A-94-52120-098
Other IDs
2004-002086-20, 2004
Status last verified
Mar 2023
First submitted
13 Mar 2007
Last updated
30 Mar 2023
Data monitoring committee
No

Publications

  • 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.

    PubMed 23604344

  • 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.

    PubMed 22021883

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Botulinum toxin type A in people with Cervical Dystonia, run by Ipsen at 106 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline to Week 4 or Week 12 (up to 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00447772, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.

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