ULIS2: To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke
Sponsor
Ipsen (Industry)
Overall Status
Completed
CT.gov ID
NCT01020500
Collaborator
(none)
469
96
15.9
4.9
0.3
Study Details
Study Description
Brief Summary
The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
469 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An International, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Upper Limb Spasticity Following Stroke
Study Start Date
:
Jan 1, 2010
Actual Primary Completion Date
:
May 1, 2011
Actual Study Completion Date
:
May 1, 2011
Outcome Measures
Primary Outcome Measures
- Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS) following one BoNT-A injection cycle in accordance with routine practices [Around 3 to 5 months post injection]
Secondary Outcome Measures
- Overall attainment of the treatment goals using the GAS T score [Around 3 to 5 months post injection]
- Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test) [Around 3 to 5 months post injection]
- Global assessment of benefits by both the investigator and the subject (or guardian) [Around 3 to 5 months post injection]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Upper limb spasticity following stroke
-
At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion
-
Decision already been agreed to inject BoNT-A
-
Agreement with the subject on goal setting
Exclusion Criteria:
- Contraindications to any BoNT-A preparations
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rankin Park (site 036006) | Newcastle | Australia | ||
| 2 | Northshore Private Hospital (site 036003) | Sydney | Australia | ||
| 3 | Royal Prince Alfred Hospital (site 036005) | Sydney | Australia | ||
| 4 | Ryde Rehabilitation Center (site 036002) | Sydney | Australia | ||
| 5 | St Joseph's Hospital (site 036004) | Sydney | Australia | ||
| 6 | St Vincent's Hospital (site 036001) | Sydney | Australia | ||
| 7 | NÖ LKH Grimmenstein-Hochegg (site 040002) | Grimmenstein | Austria | ||
| 8 | Gaital-Kliniken Hermagor (site 040001) | Hermagor | Austria | ||
| 9 | Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001) | Antwerpen | Belgium | 2050 | |
| 10 | AZ St. Jan, Ruddershove 10, (site 056002) | Brugge | Belgium | 8000 | |
| 11 | UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004) | Bruxelles | Belgium | 1200 | |
| 12 | Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003) | Yvoir | Belgium | 5530 | |
| 13 | Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001) | Hong Kong | China | ||
| 14 | Faculty Hospital Brno (site 203002) | Brno | Czechia | ||
| 15 | Hospital Pardubice, Neurology dept. (site 203001) | Pardubice | Czechia | ||
| 16 | Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001) | Aarhus | Denmark | ||
| 17 | Herlev Hospital, Herlev Ringvej (Site 208004) | Copenhagen | Denmark | ||
| 18 | Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003) | Glostrup | Denmark | ||
| 19 | Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005) | Jyväskylä | Finland | ||
| 20 | Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004) | Rovaniemi | Finland | ||
| 21 | Neurologiska Polikliniken, Tampere University Hospital (site 246001) | Tampere | Finland | ||
| 22 | Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008) | Angers | France | Cedex 02 | |
| 23 | Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021) | Argonay | France | ||
| 24 | Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016) | Besançon | France | ||
| 25 | Hôpital Pellegrin/Rééducation fonctionnelle (site 250012) | Bordeaux | France | ||
| 26 | Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013) | Coubert | France | ||
| 27 | Hopital Albert Chenevier/Neurologie, (site 250010) | Créteil | France | ||
| 28 | CHU Hôpital SUD/Institut de Rééducation (site 250007) | Echirolles | France | ||
| 29 | Hôpital Raymond Poincaré/Rééducation neurologique (site 250002) | Garches | France | ||
| 30 | CHRU Lille/Rééducation Neurologique (site 250018) | Lille | France | ||
| 31 | Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006) | Limoges | France | CEDEX 1 | |
| 32 | Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005) | Lyon | France | CEDEX 05 | |
| 33 | Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020) | Marseille | France | CEDEX 05 | |
| 34 | CHU Lapeyronie /Rééducation fonctionnelle (site 250014) | Montpellier | France | ||
| 35 | CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017) | Nantes | France | CEDEX 1 | |
| 36 | Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001) | Paris | France | ||
| 37 | Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004) | Reims Cedex | France | ||
| 38 | Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003) | Rennes | France | CEDEX 9 | |
| 39 | Hôpital Hautepierre/Rééducation fonctionnellev (site 250011) | Strasbourg | France | CEDEX 2 | |
| 40 | Hôpital Rangueil/Médecine Physique réadaptation (site 250015) | Toulouse | France | CEDEX 9 | |
| 41 | Sächs. KH Neurologie, Hufelandstr. 15 (site 276006) | Arnsdorf | Germany | 01477 | |
| 42 | Kinik für Neurologie Paracelsusring 6a (site 276003) | Beelitz | Germany | 14547 | |
| 43 | NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1 | Bennewitz | Germany | 04828 | |
| 44 | Praxis für Neurologie, Dalberger Str. 6 (site 276007) | Frankfurt | Germany | 65929 | |
| 45 | Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005) | Hannover | Germany | 30625 | |
| 46 | Praxis für Neurologie Mittelstr. 4 (site 276008) | Mannheim | Germany | 68169 | |
| 47 | Paracelsus Klinik Werdauer Str. 68 (site 276002) | Zwickau | Germany | 08060 | |
| 48 | Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004) | Ancona | Italy | ||
| 49 | Azienda Ospedaliera Universitaria (site 380012) | Ferrara | Italy | ||
| 50 | Ospedale Valduce, Costa Masnaga (site 380001) | Lecco | Italy | ||
| 51 | Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002) | Pietra Ligure | Italy | ||
| 52 | Ospedale Cisanello (site 380010) | Pisa | Italy | ||
| 53 | Ospedale S. Bartolomeo (site 380005) | Sarzana | Italy | ||
| 54 | Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004) | Daejeon | Korea, Republic of | 520-2 | |
| 55 | Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006) | Incheon | Korea, Republic of | 400-711 | |
| 56 | Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002) | Seoul | Korea, Republic of | 135-710 | |
| 57 | Dept. for Rehabilitation Asan Medical Center (site 410005) | Seoul | Korea, Republic of | ||
| 58 | Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003) | Seoul | Korea, Republic of | ||
| 59 | Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001) | Seoul | Korea, Republic of | ||
| 60 | Hospital Kuala Lumpur (site 458002) | Kuala Lumpur | Malaysia | ||
| 61 | Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001) | Kuala Lumpur | Malaysia | ||
| 62 | Colonia Ladrón de Guevara (Site 484001) | Guadalajara | Jalisco | Mexico | |
| 63 | Angeles del Pedregal (Site 484002) | México City | Mexico | ||
| 64 | Perpetual Succour Hospital (site 608002) | Cebu City | Philippines | ||
| 65 | Metropolitan Medical Center (site 608001) | Manila | Philippines | ||
| 66 | Centro de Medicina de Reabilitação de Alcoitão (site 620001) | Alcabideche | Portugal | ||
| 67 | Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005) | Coimbra | Portugal | ||
| 68 | Hospital Distrital de Faro (site 620004) | Faro | Portugal | ||
| 69 | Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003) | Lisboa | Portugal | ||
| 70 | Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002) | Porto | Portugal | ||
| 71 | Municipal health care institution "City clinical hospital #3" (site 643006) | Chelyabinsk | Russian Federation | ||
| 72 | State Institution "Interregional clinical diagnostic centre" (site 643002) | Kazan | Russian Federation | ||
| 73 | Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004) | Krasnodar | Russian Federation | ||
| 74 | State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007) | Krasnoyarsk | Russian Federation | ||
| 75 | Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001) | Moscow | Russian Federation | ||
| 76 | State Novosibirsk Regional Clinical Diagnostic Centre (site 643005) | Novosibirsk | Russian Federation | ||
| 77 | State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003) | St-Peterburg | Russian Federation | ||
| 78 | Singapore General Hospital, Department of Rehabilitation Medicine (site 702002) | Singapore | Singapore | ||
| 79 | Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001) | Singapore | Singapore | ||
| 80 | Hospital La Paz / Servicio de Rehabilitación (site 724006) | Madrid | Spain | ||
| 81 | Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005) | Murcia | Spain | ||
| 82 | Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009) | Santander | Spain | ||
| 83 | Hospital Universitario La Fe (Site 724003) | Valencia | Spain | ||
| 84 | Mälarsjukhuset, Dept. Of Neurology (site 752001) | Eskilstuna | Sweden | ||
| 85 | Dept. Of Neurology, Nyköping Hospital (site 752002) | Nyköping | Sweden | ||
| 86 | Läkarhuset Odenplan, Neuro Unit (site 752003) | Stockholm | Sweden | ||
| 87 | Östersunds Rehab Centrum (site 752004) | Östersund | Sweden | ||
| 88 | China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002) | Taichung | Taiwan | ||
| 89 | Veteran General Hospital (site 158001) | Taipei | Taiwan | ||
| 90 | King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002) | Bangkok | Thailand | ||
| 91 | Siriraj Hospital/Department of Rehabilitation Medicine (site 764001) | Bangkok | Thailand | ||
| 92 | Dewsbury District Hospital (site 826004) | Dewsbury | United Kingdom | WF13 4HS | |
| 93 | Medway Maritime Hospital (site 826002) | Gillingham | United Kingdom | ME7 5NY | |
| 94 | Lincoln County Hospital (site 826001) | Lincoln | United Kingdom | LN2 5QY | |
| 95 | Regional Rehabilitation Unit, Northwick Park Hospital (site 826006) | Middlesex | United Kingdom | HA1 3UJ | |
| 96 | West Midlands/Rehabilitation Centre (826005) | Plymouth | United Kingdom |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Study Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ipsen
ClinicalTrials.gov Identifier:
NCT01020500
Other Study ID Numbers:
- Y-79-52120-138
First Posted:
Nov 25, 2009
Last Update Posted:
Nov 6, 2020
Last Verified:
Nov 1, 2020
Additional relevant MeSH terms: