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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002086-20 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A | Biological | Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | Baseline to Week 4 or Week 12 (up to 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus der Barmherzigen Brüder | Graz | A-8020 | Austria | |||
| NÖ LKH Grimmenstein-Hochegg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23604344 | Result | 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. | |
| 22021883 | Result |
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To be eligible patients had to have 2 of the most frequent forms of cervical dystonia (CD): rotatory torticollis or laterocollis.
First patient enrolled (signed informed consent) 28 Oct 2004, last patient completed 4 April 2008. 516 patients were recruited to this prospective, open, multicentre study at 77 study centres in Germany and 4 study centres in Austria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dysport® 500 U - Total Study Population | Patients with heterogeneous forms of CD were given a single intramuscular (i.m.) injection of 500 units (U) Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 millilitres (ml) 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments. The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 12 |
| 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:
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. | Baseline to Week 4 and Week 12 |
| 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:
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. | Baseline to Week 4 and Week 12 |
| 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. | Baseline to Week 4 and Week 12 |
| 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. | Baseline to Week 4 and Week 12 |
| 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. | Baseline to Week 4 and Week 12 |
| 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:
The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented. | Week 4 visit and Week 12 visit |
| 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:
The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented. | Week 4 and Week 12 |
| Grimmenstein |
| A-2240 |
| Austria |
| Univ.-Klinik für Neurologie | Innsbruck | A-6020 | Austria |
| Konventhospital der Barmherzigen Brüder | Linz | A-4014 | Austria |
| O.Ö. Landes-Nervenklinik Wagner-Jauregg | Linz | A-4020 | Austria |
| Neurolog. Klinik des RWTH Aachen | Aachen | 52074 | Germany |
| Praxis für Anästhesiologie | Ahaus | 48683 | Germany |
| Praxis für Neurologie und Psychiatrie | Apolda | 99510 | Germany |
| Sächsisches Krankenhaus | Arnsdorf | 01477 | Germany |
| Praxis für Neurologie | Aschaffenburg | 63739 | Germany |
| Klinikum für Rehabilitation | Bad Oeynhausen | 32545 | Germany |
| Praxis für Neurologie | Bad Reichenhall | 83435 | Germany |
| Krankenhaus Hohe Warte | Bayreuth | 95445 | Germany |
| Neurologische Rehabilitationsklinik | Beelitz | 14547 | Germany |
| NRZ Neurologisches Rehabilitationszentrum Leipzig | Bennewitz | 04828 | Germany |
| Praxis für Neurologie | Berlin | 10178 | Germany |
| Neurologisches Facharztzentrum am St.-Gertrauden-KH | Berlin | 10713 | Germany |
| Praxis für Neurologie | Berlin | 10719 | Germany |
| Universitätsklinikum Charité, Campus Benjamin Franklin | Berlin | 12200 | Germany |
| Universitätsklinikum Charité, Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Gemeinschaftspraxis für Neurologie | Berlin | 14050 | Germany |
| Krankenhaus Henningsdorf | Berlin | Germany |
| SALUS Fachkrankenhaus Bernburg | Bernburg | 06406 | Germany |
| Neurologische Klinik GILEAD im Evang. KH Bielefeld EVKB | Bielefeld | 33617 | Germany |
| Praxis für Neurologie | Bochum | 44787 | Germany |
| Berufsg. Kliniken Bergmannsheil | Bochum | 44789 | Germany |
| St.-Josef-Hospital | Bochum | 44791 | Germany |
| Medizinische Einrichtung Rhein. F.-Wilhelms-Universität Bonn | Bonn | 53105 | Germany |
| Zentralkrankenhaus Bremen-Ost | Bremen | 28325 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09131 | Germany |
| Klinikum Koeln-Merheim | Cologne | Germany |
| Praxis für Neurologie | Dachau | 85221 | Germany |
| Bezirksklinikum Mainkofen | Deggendorf | 94469 | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Malteser Krankenhaus St. Anna | Duisburg | 47259 | Germany |
| University Hospital, Neurology Clinic | Düsseldorf | 40225 | Germany |
| Landesklinik Eberswalde | Eberswalde | 16225 | Germany |
| HELIOS Klinikum Erfurt | Erfurt | 99089 | Germany |
| Uniklinik Erlangen | Erlangen | 91054 | Germany |
| Alfried-Krupp-Krankenhaus | Essen | 45117 | Germany |
| Universitätsklinik Essen | Essen | 45147 | Germany |
| Kreiskrankenhaus Freiberg | Freiberg | 09599 | Germany |
| Zentrum für Neurologie | Giessen | 35385 | Germany |
| Praxis für Neurologie | Giessen | 35390 | Germany |
| Praxis für Neurologie und Psychiatrie | Giessen | 35392 | Germany |
| Sächsisches Krankenhaus für Psychiatrie, Psychotherapie und Neurolgie | Großschweidnitz | '02708 | Germany |
| Bezirkskrankenhaus Günzburg | Günzburg | 89312 | Germany |
| Klinikum Ambrock | Hagen | 58091 | Germany |
| Katholisches Krankenhaus Hagen | Hagen | 58099 | Germany |
| Städt. Krankenhaus Martha-Maria | Halle | 06120 | Germany |
| Gemeinschaftspraxis für Neurologie | Hamburg | 20249 | Germany |
| Praxis für Neurologie | Hamburg | 22525 | Germany |
| Neurologische Uniklinik | Hanover | Germany |
| Praxis für Neurologie | Hanover | Germany |
| Universitätskliniken des Saarlandes | Homburg | 66421 | Germany |
| Gemeinschaftspraxis für Neurologie/Psychiatrie | Ilmenau | 98693 | Germany |
| Praxis für Neurologie | Itzehoe | 25524 | Germany |
| Uniklinik Jena | Jena | 07743 | Germany |
| Westpfalz-Klinikum GmbH | Kaiserslautern | 67655 | Germany |
| Universitätsklinikum Kiel | Kiel | 24105 | Germany |
| Kath. Klinikum/Brüderkrankenhaus | Koblenz | 56073 | Germany |
| Neurologische Praxis | Landshut | 84028 | Germany |
| Universitätsklinikum Leipzig | Leipzig | 04103 | Germany |
| Gemeinschaftspraxis für Neurologie/Psychiatrie | Leipzig | 04155 | Germany |
| Gemeinschaftspraxis für Neurologie | Leipzig | 04229 | Germany |
| Klinikum Lippe-Lemgo GmbH | Lemgo | 32657 | Germany |
| Klinikum der Stadt Ludwigshafen | Ludwigshafen | 67063 | Germany |
| Universitätsklinikum | Lübeck | 23562 | Germany |
| Gemeinschaftspraxis für Neurologie/Psychiatrie | Lüneburg | 21335 | Germany |
| Universitätsklinikum | Magdeburg | 39120 | Germany |
| Universitätsklinikum | Mainz | 55131 | Germany |
| Klinikum Mannheim | Mannheim | 68167 | Germany |
| Praxis für Neurologie | Mannheim | 68169 | Germany |
| Klinikum Minden | Minden | 32427 | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | 41063 | Germany |
| Neurologisches Krankenhaus München | München | 80804 | Germany |
| Klinikum rechts der Isar | München | 81675 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Praxis für Neurologie und Nervenheilkunde | Neubrandenburg | 17033 | Germany |
| Klinikum Nürnberg-Süd | Nuremberg | 90471 | Germany |
| Evangelisches Krankenhaus Oldenburg | Oldenburg | 26122 | Germany |
| Praxis für Neurologie und Psychiatrie | Ostfildern | 73760 | Germany |
| St. Vincenz-Krankenhaus GmbH | Paderborn | 33098 | Germany |
| St.-Josefs-Krankenhaus | Potsdam | 11471 | Germany |
| Klinikum Ernst von Bergmann | Potsdam | 14467 | Germany |
| Zentrum für Psychiatrie Weissenau | Ravensburg | 88214 | Germany |
| Knappschafts-Krankenhaus | Recklinghausen | 45657 | Germany |
| Universitätsklinikum | Rostock | 18147 | Germany |
| Evang.-Freichkirchl. Krankenhaus | Rüdersdorf | 15562 | Germany |
| Praxis für Neurologie | Schorndorf | 73614 | Germany |
| Klinikum Uckermark GmbH | Schwedt | 16303 | Germany |
| HELIOS Kliniken Schwerin | Schwerin | 19055 | Germany |
| Asklepios Kliniken Schildautal | Seesen | 38723 | Germany |
| EMSA | Singen | 78224 | Germany |
| Landesfachkrankenhaus für Psychatrie und Neurologie | Stadtroda | 07646 | Germany |
| Praxis für Neurologie | Stralsund | 18439 | Germany |
| Neurologische Praxis | Straubing | 94315 | Germany |
| Landesklinik Teupitz | Teupitz | 15775 | Germany |
| Zentrum für Neurologie und Hertie-Institut für Klinische Hirnforschung | Tübingen | 72076 | Germany |
| Klinikum Weiden | Weiden | 92637 | Germany |
| Stiftung Deutsche Klinik für Diagnostik | Wiesbaden | 65191 | Germany |
| Gemeinschaftspraxis für Neurologie | Wolfenbüttel | 38300 | Germany |
| Klinikum Wuppertal | Wuppertal | 42283 | Germany |
| Medizinisches Studienzentrum | Würzburg | 97070 | Germany |
| Universitätsklinikum Würzburg | Würzburg | 97070 | Germany |
| Paracelsus Klinik | Zwickau | 08060 | Germany |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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|
Baseline characteristics are reported for the Safety Population which included all patients who received the study medication and for who any safety data were recorded. All 516 patients who were enrolled received study medication. However, for one patient no safety data were available for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dysport® 500 U - Total Study Population | Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments. The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
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. | The Intention to Treat (ITT) Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 or Week 12 (up to 12 weeks) |
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| Secondary | 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:
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. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for the Week 12 visit are reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 12 |
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| Secondary | 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:
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. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 and Week 12 |
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| Secondary | 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:
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. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 and Week 12 |
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| Secondary | 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. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 and Week 12 |
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| Secondary | 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. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 4 and Week 12 |
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| Secondary | 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. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported. | Posted | Number | percentage of patients | Baseline to Week 4 and Week 12 |
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| Secondary | 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:
The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported. | Posted | Number | Participants | Week 4 visit and Week 12 visit |
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| Secondary | 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:
The numbers of patients falling under each of these categories as assessed by the investigator and patient at Weeks 4 and 12 are presented. | The ITT Population included all patients in the safety population with a baseline visit (Week 0) and a post-baseline (Week 4 or Week 12) assessment of the Tsui rating scale. Only patients with data available for each indicated timepoint are reported. | Posted | Number | Participants | Week 4 and Week 12 |
|
|
From Visit 1 (Week 0) to Visit 3 (Week 12) for each patient.
All adverse events are reported as treatment emergent adverse events. The Safety Population includes all patients who received the study medication and for whom any safety data were recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dysport® 500 U - Total Study Population | Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments. The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments. | 0 | 515 | 11 | 515 | 206 | 515 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Blindness | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Apathy | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Circulatory collapse | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Limb operation | Surgical and medical procedures | MedDRA 9.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Conversion disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Middle insomnia | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Blood pressure diastolic increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood pressure orthostatic abnormal | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Cervical root pain | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Head titubation | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Mastication disorder | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Neuritis | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Paresis | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tongue paralysis | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Eyelid ptosis | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Keratoconjunctivitis sicca | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Trismus | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Eye infection viral | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Neurology | Ipsen | clinical.trials@ipsen.com |
| ID | Term |
|---|---|
| D014103 | Torticollis |
| ID | Term |
|---|---|
| D004421 | Dystonia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| C542869 | abobotulinumtoxinA |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided
| OG002 | Dysport® 500 U - Total Study Population | Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments. The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments. |
|
|
| OG002 | Dysport® 500 U - Total Study Population | Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments. The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments. |
|
|
Patients with laterocollis type of CD who received a single i.m. injection of 500 U Dysport®. |
| OG002 | Dysport® 500 U - Total Study Population | Patients with heterogeneous forms of CD were given a single i.m. injection of 500 U Dysport® at the first study visit (Week 0). The single injection of 500 U Dysport® was diluted in 2.5 ml 0.9% sodium chloride (= 200 units/ml). Patients were treated according to one of 12 possible basic patterns of injection protocol to allow individual treatment of the muscles affected as well as providing an algorithm for the individual first treatments. The patients visited the study centres at Week 4 and Week 12 post-dose for safety and efficacy assessments. |
|
|
|
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| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
|
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| Participants |
|
|