To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke (ULIS2)
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT01020500
First received: November 24, 2009
Last updated: June 20, 2011
Last verified: June 2011
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Purpose
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 |
|---|
|
Muscle Spasticity |
| Study Type: | Observational |
| Study Design: | 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 |
Further study details as provided by Ipsen:
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 [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall attainment of the treatment goals using the GAS T score [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]
- Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test) [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]
- Global assessment of benefits by both the investigator and the subject (or guardian) [ Time Frame: Around 3 to 5 months post injection ] [ Designated as safety issue: No ]
| Enrollment: | 469 |
| Study Start Date: | January 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Hospital Clinics
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020500
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Hide Study LocationsLocations
| Australia | |
| Rankin Park (site 036006) | |
| Newcastle, Australia | |
| St Vincent's Hospital (site 036001) | |
| Sydney, Australia | |
| Northshore Private Hospital (site 036003) | |
| Sydney, Australia | |
| St Joseph's Hospital (site 036004) | |
| Sydney, Australia | |
| Royal Prince Alfred Hospital (site 036005) | |
| Sydney, Australia | |
| Ryde Rehabilitation Center (site 036002) | |
| Sydney, Australia | |
| Austria | |
| NÖ LKH Grimmenstein-Hochegg (site 040002) | |
| Grimmenstein-Hochegg, Austria | |
| Gaital-Kliniken Hermagor (site 040001) | |
| Hermagor, Austria | |
| Belgium | |
| Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001) | |
| Antwerpen, Belgium, 2050 | |
| AZ St. Jan, Ruddershove 10, (site 056002) | |
| Brugge, Belgium, 8000 | |
| UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004) | |
| Bruxelles, Belgium, 1200 | |
| Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003) | |
| Yvoir, Belgium, 5530 | |
| China | |
| Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001) | |
| Hong Kong, China | |
| Czech Republic | |
| Faculty Hospital Brno (site 203002) | |
| Brno, Czech Republic | |
| Hospital Pardubice, Neurology dept. (site 203001) | |
| Pardubice, Czech Republic | |
| Denmark | |
| Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001) | |
| Aarhus, Denmark | |
| Herlev Hospital, Herlev Ringvej (Site 208004) | |
| Copenhagen, Denmark | |
| Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003) | |
| Glostrup, Denmark | |
| Finland | |
| Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005) | |
| Jyväskylä, Finland | |
| Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004) | |
| Rovaniemi, Finland | |
| Neurologiska Polikliniken, Tampere University Hospital (site 246001) | |
| Tampere, Finland | |
| France | |
| Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008) | |
| Angers, France, Cedex 02 | |
| Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021) | |
| Argonay, France | |
| Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016) | |
| Besançon, France | |
| Hôpital Pellegrin/Rééducation fonctionnelle (site 250012) | |
| Bordeaux, France | |
| Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013) | |
| Coubert, France | |
| Hopital Albert Chenevier/Neurologie, (site 250010) | |
| Créteil, France | |
| CHU Hôpital SUD/Institut de Rééducation (site 250007) | |
| Echirolles, France | |
| Hôpital Raymond Poincaré/Rééducation neurologique (site 250002) | |
| Garches, France | |
| CHRU Lille/Rééducation Neurologique (site 250018) | |
| Lille, France | |
| Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006) | |
| Limoges, France, CEDEX 1 | |
| Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005) | |
| Lyon, France, CEDEX 05 | |
| Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020) | |
| Marseille, France, CEDEX 05 | |
| CHU Lapeyronie /Rééducation fonctionnelle (site 250014) | |
| Montpellier, France | |
| CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017) | |
| Nantes, France, CEDEX 1 | |
| Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001) | |
| Paris, France | |
| Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004) | |
| Reims Cedex, France | |
| Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003) | |
| Rennes, France, CEDEX 9 | |
| Hôpital Hautepierre/Rééducation fonctionnellev (site 250011) | |
| Strasbourg, France, CEDEX 2 | |
| Hôpital Rangueil/Médecine Physique réadaptation (site 250015) | |
| Toulouse, France, CEDEX 9 | |
| Germany | |
| Sächs. KH Neurologie, Hufelandstr. 15 (site 276006) | |
| Arnsdorf, Germany, 01477 | |
| Kinik für Neurologie Paracelsusring 6a (site 276003) | |
| Beelitz, Germany, 14547 | |
| NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1 | |
| Bennewitz, Germany, 04828 | |
| Praxis für Neurologie, Dalberger Str. 6 (site 276007) | |
| Frankfurt, Germany, 65929 | |
| Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005) | |
| Hannover, Germany, 30625 | |
| Praxis für Neurologie Mittelstr. 4 (site 276008) | |
| Mannheim, Germany, 68169 | |
| Paracelsus Klinik Werdauer Str. 68 (site 276002) | |
| Zwickau, Germany, 08060 | |
| Italy | |
| Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004) | |
| Ancona, Italy | |
| Azienda Ospedaliera Universitaria (site 380012) | |
| Ferrara, Italy | |
| Ospedale Valduce, Costa Masnaga (site 380001) | |
| Lecco, Italy | |
| Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002) | |
| Pietra Ligure, Italy | |
| Ospedale Cisanello (site 380010) | |
| Pisa, Italy | |
| Ospedale S. Bartolomeo (site 380005) | |
| Sarzana, Italy | |
| Korea, Republic of | |
| Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003) | |
| Bundang, Korea, Republic of | |
| Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004) | |
| Deajeon, Korea, Republic of, 520-2 | |
| Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006) | |
| Incheon, Korea, Republic of, 400-711 | |
| Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001) | |
| Seoul, Korea, Republic of | |
| Dept. for Rehabilitation Asan Medical Center (site 410005) | |
| Seoul, Korea, Republic of | |
| Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002) | |
| Seoul, Korea, Republic of, 135-710 | |
| Malaysia | |
| Hospital Kuala Lumpur (site 458002) | |
| Jalan Pahang, Malaysia | |
| Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001) | |
| Kuala Lumpur, Malaysia | |
| Mexico | |
| Colonia Ladrón de Guevara (Site 484001) | |
| Guadalajara, Jalisco, Mexico | |
| Angeles del Pedregal (Site 484002) | |
| México City, Mexico | |
| Philippines | |
| Perpetual Succour Hospital (site 608002) | |
| Cebu City, Philippines | |
| Metropolitan Medical Center (site 608001) | |
| Manila, Philippines | |
| Portugal | |
| Centro de Medicina de Reabilitação de Alcoitão (site 620001) | |
| Alcabideche, Portugal | |
| Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005) | |
| Coimbra, Portugal | |
| Hospital Distrital de Faro (site 620004) | |
| Faro, Portugal | |
| Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003) | |
| Lisboa, Portugal | |
| Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002) | |
| Porto, Portugal | |
| Russian Federation | |
| Municipal health care institution "City clinical hospital #3" (site 643006) | |
| Chelyabinsk, Russian Federation | |
| State Institution "Interregional clinical diagnostic centre" (site 643002) | |
| Kazan, Russian Federation | |
| Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004) | |
| Krasnodar, Russian Federation | |
| State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007) | |
| Krasnoyarsk, Russian Federation | |
| Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001) | |
| Moscow, Russian Federation | |
| State Novosibirsk Regional Clinical Diagnostic Centre (site 643005) | |
| Novosibirsk, Russian Federation | |
| 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 | |
| Singapore | |
| Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001) | |
| Singapore, Singapore | |
| Singapore General Hospital, Department of Rehabilitation Medicine (site 702002) | |
| Singapore, Singapore | |
| Spain | |
| Hospital La Paz / Servicio de Rehabilitación (site 724006) | |
| Madrid, Spain | |
| Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005) | |
| Murcia, Spain | |
| Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009) | |
| Santander, Spain | |
| Hospital Universitario La Fe (Site 724003) | |
| Valencia, Spain | |
| Sweden | |
| Mälarsjukhuset, Dept. Of Neurology (site 752001) | |
| Eskilstuna, Sweden | |
| Dept. Of Neurology, Nyköping Hospital (site 752002) | |
| Nyköping, Sweden | |
| Läkarhuset Odenplan, Neuro Unit (site 752003) | |
| Stockholm, Sweden | |
| Östersunds Rehab Centrum (site 752004) | |
| Östersund, Sweden | |
| Taiwan | |
| China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002) | |
| Taichung, Taiwan | |
| Veteran General Hospital (site 158001) | |
| Taipei, Taiwan | |
| Thailand | |
| King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002) | |
| Bangkok, Thailand | |
| Siriraj Hospital/Department of Rehabilitation Medicine (site 764001) | |
| Bangkok, Thailand | |
| United Kingdom | |
| Dewsbury District Hospital (site 826004) | |
| Dewsbury, United Kingdom, WF13 4HS | |
| Medway Maritime Hospital (site 826002) | |
| Kent, United Kingdom, ME7 5NY | |
| Lincoln County Hospital (site 826001) | |
| Lincoln, United Kingdom, LN2 5QY | |
| Regional Rehabilitation Unit, Northwick Park Hospital (site 826006) | |
| Middlesex, United Kingdom, HA1 3UJ | |
| West Midlands/Rehabilitation Centre (826005) | |
| Plymouth, United Kingdom | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Study Director | Ipsen |
More Information
No publications provided
| Responsible Party: | Ipsen Study Director, Ipsen |
| ClinicalTrials.gov Identifier: | NCT01020500 History of Changes |
| Other Study ID Numbers: | Y-79-52120-138 |
| Study First Received: | November 24, 2009 |
| Last Updated: | June 20, 2011 |
| Health Authority: | China: Ministry of Health Czech Republic: State Institute for Drug Control France: French Data Protection Authority Mexico: Federal Commission for Sanitary Risks Protection Portugal: Data Protection Authority (CNPD) Spain: Local Regulatory Authority ("Comunidad Autónoma") |
Additional relevant MeSH terms:
|
Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia |
Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013