To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke (ULIS2)

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT01020500
First received: November 24, 2009
Last updated: June 20, 2011
Last verified: June 2011
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020500

  Hide Study Locations
Locations
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 July 26, 2014