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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01020500
Other study ID # Y-79-52120-138
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2010
Est. completion date May 2011

Study information

Verified date November 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 469
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Australia Rankin Park (site 036006) Newcastle
Australia Northshore Private Hospital (site 036003) Sydney
Australia Royal Prince Alfred Hospital (site 036005) Sydney
Australia Ryde Rehabilitation Center (site 036002) Sydney
Australia St Joseph's Hospital (site 036004) Sydney
Australia St Vincent's Hospital (site 036001) Sydney
Austria NÖ LKH Grimmenstein-Hochegg (site 040002) Grimmenstein
Austria Gaital-Kliniken Hermagor (site 040001) Hermagor
Belgium Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001) Antwerpen
Belgium AZ St. Jan, Ruddershove 10, (site 056002) Brugge
Belgium UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004) Bruxelles
Belgium Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003) Yvoir
China Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001) Hong Kong
Czechia Faculty Hospital Brno (site 203002) Brno
Czechia Hospital Pardubice, Neurology dept. (site 203001) Pardubice
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
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
France Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008) Angers
France 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 Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005) Lyon
France Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020) Marseille
France CHU Lapeyronie /Rééducation fonctionnelle (site 250014) Montpellier
France CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017) Nantes
France 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 Hôpital Hautepierre/Rééducation fonctionnellev (site 250011) Strasbourg
France Hôpital Rangueil/Médecine Physique réadaptation (site 250015) Toulouse
Germany Sächs. KH Neurologie, Hufelandstr. 15 (site 276006) Arnsdorf
Germany Kinik für Neurologie Paracelsusring 6a (site 276003) Beelitz
Germany NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1 Bennewitz
Germany Praxis für Neurologie, Dalberger Str. 6 (site 276007) Frankfurt
Germany Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005) Hannover
Germany Praxis für Neurologie Mittelstr. 4 (site 276008) Mannheim
Germany Paracelsus Klinik Werdauer Str. 68 (site 276002) Zwickau
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
Korea, Republic of Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004) Daejeon
Korea, Republic of Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006) Incheon
Korea, Republic of Dept. for Rehabilitation Asan Medical Center (site 410005) Seoul
Korea, Republic of Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003) Seoul
Korea, Republic of Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001) Seoul
Korea, Republic of Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002) Seoul
Malaysia Hospital Kuala Lumpur (site 458002) Kuala Lumpur
Malaysia Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001) Kuala Lumpur
Mexico Colonia Ladrón de Guevara (Site 484001) Guadalajara Jalisco
Mexico Angeles del Pedregal (Site 484002) México City
Philippines Perpetual Succour Hospital (site 608002) Cebu City
Philippines Metropolitan Medical Center (site 608001) Manila
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
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
Singapore Singapore General Hospital, Department of Rehabilitation Medicine (site 702002) Singapore
Singapore Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001) 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
Sweden Mälarsjukhuset, Dept. Of Neurology (site 752001) Eskilstuna
Sweden Dept. Of Neurology, Nyköping Hospital (site 752002) Nyköping
Sweden Östersunds Rehab Centrum (site 752004) Östersund
Sweden Läkarhuset Odenplan, Neuro Unit (site 752003) Stockholm
Taiwan China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002) Taichung
Taiwan Veteran General Hospital (site 158001) Taipei
Thailand King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002) Bangkok
Thailand Siriraj Hospital/Department of Rehabilitation Medicine (site 764001) Bangkok
United Kingdom Dewsbury District Hospital (site 826004) Dewsbury
United Kingdom Medway Maritime Hospital (site 826002) Gillingham
United Kingdom Lincoln County Hospital (site 826001) Lincoln
United Kingdom Regional Rehabilitation Unit, Northwick Park Hospital (site 826006) Middlesex
United Kingdom West Midlands/Rehabilitation Centre (826005) Plymouth

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Italy,  Korea, Republic of,  Malaysia,  Mexico,  Philippines,  Portugal,  Russian Federation,  Singapore,  Spain,  Sweden,  Taiwan,  Thailand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall attainment of the treatment goals using the GAS T score Around 3 to 5 months post injection
Secondary Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test) Around 3 to 5 months post injection
Secondary Global assessment of benefits by both the investigator and the subject (or guardian) Around 3 to 5 months post injection
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