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

NCT01020500 | Completed

• 1 other identifier: Y-79-52120-138
• Study Type: observational
• Target: 469
• Locations: 21 countries
• Sites: 90

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.

Conditions

Muscle Spasticity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital Clinics

You may qualify if:

• Upper limb spasticity following stroke
• Decision already been agreed to inject BoNT-A
• Agreement with the subject on goal setting

You may not qualify if:

• Contraindications to any BoNT-A preparations

Sponsors & Collaborators

• Ipsen: lead

Study Sites (96)

Rankin Park (site 036006)

Newcastle, Australia

Location

Northshore Private Hospital (site 036003)

Sydney, Australia

Location

Royal Prince Alfred Hospital (site 036005)

Sydney, Australia

Location

Ryde Rehabilitation Center (site 036002)

Sydney, Australia

Location

St Joseph's Hospital (site 036004)

Sydney, Australia

Location

St Vincent's Hospital (site 036001)

Sydney, Australia

Location

NÖ LKH Grimmenstein-Hochegg (site 040002)

Grimmenstein, Austria

Location

Gaital-Kliniken Hermagor (site 040001)

Hermagor, Austria

Location

Revalidatieziekenhuis Hof ter Schelde, August Vermeylenlaan 6 (site 056001)

Antwerp, 2050, Belgium

Location

AZ St. Jan, Ruddershove 10, (site 056002)

Bruges, 8000, Belgium

Location

UCL St. Luc Département de médecine, physique et de readaptation motrice, Avenue Hippocrate 10 (site 056004)

Brussels, 1200, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne, Avenue Dr. G. Therasse (site 056003)

Yvoir, 5530, Belgium

Location

Rehabilitation Unit, Tung Wah Hospital, 12 Po Yan Street, Sheung Wan (site 344001)

Hong Kong, China

Location

Faculty Hospital Brno (site 203002)

Brno, Czechia

Location

Hospital Pardubice, Neurology dept. (site 203001)

Pardubice, Czechia

Location

Aarhus University Hospital, Neurolog avd.F-NEU-Cent (Site 208001)

Aarhus, Denmark

Location

Herlev Hospital, Herlev Ringvej (Site 208004)

Copenhagen, Denmark

Location

Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)

Glostrup Municipality, Denmark

Location

Department of Physical and Rehabilitation Medicine/Central Hospital of Central Finland (Site 246005)

Jyväskylä, Finland

Location

Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004)

Rovaniemi, Finland

Location

Neurologiska Polikliniken, Tampere University Hospital (site 246001)

Tampere, Finland

Location

Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008)

Angers, Cedex 02, France

Location

Centre de Rééducation Fonctionnelle du Mont Veyrier Rééducation fonctionnelle (site 250021)

Argonay, France

Location

Hôpital Jean Minjoz/Méd.physique réadaptation (site 250016)

Besançon, France

Location

Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)

Bordeaux, France

Location

Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)

Coubert, France

Location

Hopital Albert Chenevier/Neurologie, (site 250010)

Créteil, France

Location

CHU Hôpital SUD/Institut de Rééducation (site 250007)

Échirolles, France

Location

Hôpital Raymond Poincaré/Rééducation neurologique (site 250002)

Garches, France

Location

CHRU Lille/Rééducation Neurologique (site 250018)

Lille, France

Location

Hopital Jean Rebeyrol/Médecine Physique et de Réadaptation (site 250006)

Limoges, CEDEX 1, France

Location

Centre Médico-Chirurgical de Réadaptation des Massues (Site 250005)

Lyon, CEDEX 05, France

Location

Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)

Marseille, CEDEX 05, France

Location

CHU Lapeyronie /Rééducation fonctionnelle (site 250014)

Montpellier, France

Location

CHU de Nantes/Médecine physique et de réadaptation neurologique (site 250017)

Nantes, CEDEX 1, France

Location

Médecine Physique et de Réadaptation Fondation Hospitalière Sainte Marie (site 250001)

Paris, France

Location

Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)

Reims, France

Location

Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)

Rennes, CEDEX 9, France

Location

Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)

Strasbourg, CEDEX 2, France

Location

Hôpital Rangueil/Médecine Physique réadaptation (site 250015)

Toulouse, CEDEX 9, France

Location

Sächs. KH Neurologie, Hufelandstr. 15 (site 276006)

Arnsdorf, 01477, Germany

Location

Kinik für Neurologie Paracelsusring 6a (site 276003)

Beelitz, 14547, Germany

Location

NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1

Bennewitz, 04828, Germany

Location

Praxis für Neurologie, Dalberger Str. 6 (site 276007)

Frankfurt, 65929, Germany

Location

Kliniken der Medizinischen Hochschule (Neurologische Klinik), Carl-Neuberg-Str. 1 (site 276005)

Hanover, 30625, Germany

Location

Praxis für Neurologie Mittelstr. 4 (site 276008)

Mannheim, 68169, Germany

Location

Paracelsus Klinik Werdauer Str. 68 (site 276002)

Zwickau, 08060, Germany

Location

Clinica di Neuroriabilitatione - Az. Osp. Univ. Ospedali Riuniti (site 380004)

Ancona, Italy

Location

Azienda Ospedaliera Universitaria (site 380012)

Ferrara, Italy

Location

Ospedale Valduce, Costa Masnaga (site 380001)

Lecco, Italy

Location

Laboratorio analisi del Movimento U.O.R.R.F. -Ospedale Santa Corona (site 380002)

Pietra Ligure, Italy

Location

Ospedale Cisanello (site 380010)

Pisa, Italy

Location

Ospedale S. Bartolomeo (site 380005)

Sarzana, Italy

Location

Hospital Kuala Lumpur (site 458002)

Kuala Lumpur, Malaysia

Location

Universiti Malaya Medical Center/Department of Neurology / Department of Rehabilitation Medicine (site 458001)

Kuala Lumpur, Malaysia

Location

Colonia Ladrón de Guevara (Site 484001)

Guadalajara, Jalisco, Mexico

Location

Angeles del Pedregal (Site 484002)

México, Mexico

Location

Perpetual Succour Hospital (site 608002)

Cebu City, Philippines

Location

Metropolitan Medical Center (site 608001)

Manila, Philippines

Location

Centro de Medicina de Reabilitação de Alcoitão (site 620001)

Alcabideche, Portugal

Location

Centro Hospitalar de Coimbra - Quinta dos Vales (site 620005)

Coimbra, Portugal

Location

Hospital Distrital de Faro (site 620004)

Faro, Portugal

Location

Hospital Egas Moniz, Centro Hospitalar Lisboa Ocidental (site 620003)

Lisbon, Portugal

Location

Hospital Geral de Santo Antonio, Centro Hospitalar do Porto (site 620002)

Porto, Portugal

Location

Municipal health care institution "City clinical hospital #3" (site 643006)

Chelyabinsk, Russia

Location

State Institution "Interregional clinical diagnostic centre" (site 643002)

Kazan', Russia

Location

Municipal health care institution "City hospital #2 "Krasnodar Multidisciplinary medical diagnostic association" (site 643004)

Krasnodar, Russia

Location

State Educational Institution of high professional education "Krasnoyarsk State Medical Academy of Roszdrav" (site 643007)

Krasnoyarsk, Russia

Location

Federal State Institution "Medical Rehabilitation Centre of Roszdrav" (site 643001)

Moscow, Russia

Location

State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)

Novosibirsk, Russia

Location

State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav" (site 643003)

St-Peterburg, Russia

Location

Singapore General Hospital, Department of Rehabilitation Medicine (site 702002)

Singapore, Singapore

Location

Tan Tock Seng Hospital/TTSH Rehabilitation Centre (site 702001)

Singapore, Singapore

Location

Catholic University Daejeon St. Mary's Hospital, Daeheung-dong, Jung-gu, (site 410004)

Daejeon, 520-2, South Korea

Location

Inha University Hospital, #7-206 Shinheungdong-ga,Jjung-gu (site 410006)

Incheon, 400-711, South Korea

Location

Samsung Medical Center, #50 Ilwon-dong, Gangnam-gu (site 410002)

Seoul, 135-710, South Korea

Location

Dept. for Rehabilitation Asan Medical Center (site 410005)

Seoul, South Korea

Location

Dept. of Rehabilitation Seoul National University Bundang Hospital (site 410003)

Seoul, South Korea

Location

Dept. of Rehabilitation Yonsei University Severance Hospital (site 410001)

Seoul, South Korea

Location

Hospital La Paz / Servicio de Rehabilitación (site 724006)

Madrid, Spain

Location

Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)

Murcia, Spain

Location

Hospital Marqués de Valdecilla/ Servicio de Rehabilitación (site 724009)

Santander, Spain

Location

Hospital Universitario La Fe (Site 724003)

Valencia, Spain

Location

Mälarsjukhuset, Dept. Of Neurology (site 752001)

Eskilstuna, Sweden

Location

Dept. Of Neurology, Nyköping Hospital (site 752002)

Nyköping, Sweden

Location

Östersunds Rehab Centrum (site 752004)

Östersund, Sweden

Location

Läkarhuset Odenplan, Neuro Unit (site 752003)

Stockholm, Sweden

Location

China Medical University Hospital, Department of Physical Medicine & Rehabilitation (site 158002)

Taichung, Taiwan

Location

Veteran General Hospital (site 158001)

Taipei, Taiwan

Location

King Chulalongkorn Memorial Hospital/Department of Rehabilitation Medicine (site 764002)

Bangkok, Thailand

Location

Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)

Bangkok, Thailand

Location

Dewsbury District Hospital (site 826004)

Dewsbury, WF13 4HS, United Kingdom

Location

Medway Maritime Hospital (site 826002)

Gillingham, ME7 5NY, United Kingdom

Location

Lincoln County Hospital (site 826001)

Lincoln, LN2 5QY, United Kingdom

Location

Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)

Middlesex, HA1 3UJ, United Kingdom

Location

West Midlands/Rehabilitation Centre (826005)

Plymouth, United Kingdom

Location

Related Publications (3)

• Fheodoroff K, Ashford S, Jacinto J, Maisonobe P, Balcaitiene J, Turner-Stokes L. Factors influencing goal attainment in patients with post-stroke upper limb spasticity following treatment with botulinum toxin A in real-life clinical practice: sub-analyses from the Upper Limb International Spasticity (ULIS)-II Study. Toxins (Basel). 2015 Apr 8;7(4):1192-205. doi: 10.3390/toxins7041192.

  PMID: 25856546 DERIVED

• Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P. Results from the Upper Limb International Spasticity Study-II (ULISII):a large, international, prospective cohort study investigating practice and goal attainment following treatment with botulinum toxin A in real-life clinical management. BMJ Open. 2013 Jun 20;3(6):e002771. doi: 10.1136/bmjopen-2013-002771.

  PMID: 23794582 DERIVED

• Turner-Stokes L, Fheodoroff K, Jacinto J, Maisonobe P, Zakine B. Upper limb international spasticity study: rationale and protocol for a large, international, multicentre prospective cohort study investigating management and goal attainment following treatment with botulinum toxin A in real-life clinical practice. BMJ Open. 2013 Mar 18;3(3):e002230. doi: 10.1136/bmjopen-2012-002230.

  PMID: 23512837 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ipsen Study Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 6, 2020

Record last verified: 2020-11

Locations

FI (3); AU (2); RU (7); TW (2); TH (2); PT (5); SE (4); DE (7); KR (6); GB (5); IT (6); ME (2); PH (2); ES (4); BE (4); DK (3); MY (2); FR (19); CN (1); CZ (2); SG (2)