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Muscle SpasticityULIS2NCT01020500

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

An observational study of Muscle Spasticity, run by Ipsen at 96 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle Spasticity
How many people
469 participants
Where
96 sitesin 22 countries
Study dates
Jan 2010to May 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Hospital Clinics

Who may be able to join

  • 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

Who cannot join

  • Contraindications to any BoNT-A preparations

Trial locations and contacts

96 sites in 22 countries.

96 sites in 22 countries

France19 sites

  • Centre Régional de Rééducation et Réadaptation fonctionnelle (site 250008)

    Angers, Cedex 02

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

    Argonay

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

    Besançon

  • Hôpital Pellegrin/Rééducation fonctionnelle (site 250012)

    Bordeaux

  • Centre Médecine Physique Réadaptation/Rééducation Neurologique (site 250013)

    Coubert

  • Hopital Albert Chenevier/Neurologie, (site 250010)

    Créteil

  • CHU Hôpital SUD/Institut de Rééducation (site 250007)

    Échirolles

  • Hôpital Raymond Poincaré/Rééducation neurologique (site 250002)

    Garches

  • CHRU Lille/Rééducation Neurologique (site 250018)

    Lille

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

    Limoges, CEDEX 1

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

    Lyon, CEDEX 05

  • Hôpital Timone Adultes/Rééducation fonctionnelle (site 250020)

    Marseille, CEDEX 05

  • CHU Lapeyronie /Rééducation fonctionnelle (site 250014)

    Montpellier

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

    Nantes, CEDEX 1

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

    Paris

  • Hôpital Sébastopol/Rééducation Fonctionnelle (site 250004)

    Reims

  • Hôpital Pontchaillou/Rééducation Fonctionnelle (site 250003)

    Rennes, CEDEX 9

  • Hôpital Hautepierre/Rééducation fonctionnellev (site 250011)

    Strasbourg, CEDEX 2

  • Hôpital Rangueil/Médecine Physique réadaptation (site 250015)

    Toulouse, CEDEX 9

Other trials in France

Germany7 sites

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

    Arnsdorf, 01477

  • Kinik für Neurologie Paracelsusring 6a (site 276003)

    Beelitz, 14547

  • NRZ Neurologisches Rehazentrum (site 276004) Muldentalweg 1

    Bennewitz, 04828

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

    Frankfurt, 65929

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

    Hanover, 30625

  • Praxis für Neurologie Mittelstr. 4 (site 276008)

    Mannheim, 68169

  • Paracelsus Klinik Werdauer Str. 68 (site 276002)

    Zwickau, 08060

Other trials in Germany

Russia7 sites

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

    Chelyabinsk

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

    Kazan'

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

    Krasnodar

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

    Krasnoyarsk

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

    Moscow

  • State Novosibirsk Regional Clinical Diagnostic Centre (site 643005)

    Novosibirsk

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

    St-Peterburg

Other trials in Russia

Australia6 sites

  • Rankin Park (site 036006)

    Newcastle

  • Northshore Private Hospital (site 036003)

    Sydney

  • Royal Prince Alfred Hospital (site 036005)

    Sydney

  • Ryde Rehabilitation Center (site 036002)

    Sydney

  • St Joseph's Hospital (site 036004)

    Sydney

  • St Vincent's Hospital (site 036001)

    Sydney

Other trials in Australia

Italy6 sites

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

    Ancona

  • Azienda Ospedaliera Universitaria (site 380012)

    Ferrara

  • Ospedale Valduce, Costa Masnaga (site 380001)

    Lecco

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

    Pietra Ligure

  • Ospedale Cisanello (site 380010)

    Pisa

  • Ospedale S. Bartolomeo (site 380005)

    Sarzana

Other trials in Italy

South Korea6 sites

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

    Daejeon, 520-2

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

    Incheon, 400-711

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

    Seoul, 135-710

  • Dept. for Rehabilitation Asan Medical Center (site 410005)

    Seoul

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

    Seoul

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

    Seoul

Other trials in South Korea

Portugal5 sites

  • Centro de Medicina de Reabilitação de Alcoitão (site 620001)

    Alcabideche

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

    Coimbra

  • Hospital Distrital de Faro (site 620004)

    Faro

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

    Lisbon

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

    Porto

Other trials in Portugal

United Kingdom5 sites

  • Dewsbury District Hospital (site 826004)

    Dewsbury, WF13 4HS

  • Medway Maritime Hospital (site 826002)

    Gillingham, ME7 5NY

  • Lincoln County Hospital (site 826001)

    Lincoln, LN2 5QY

  • Regional Rehabilitation Unit, Northwick Park Hospital (site 826006)

    Middlesex, HA1 3UJ

  • West Midlands/Rehabilitation Centre (826005)

    Plymouth

Other trials in United Kingdom

Belgium4 sites

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

    Antwerp, 2050

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

    Bruges, 8000

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

    Brussels, 1200

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

    Yvoir, 5530

Other trials in Belgium

Spain4 sites

  • Hospital La Paz / Servicio de Rehabilitación (site 724006)

    Madrid

  • Hospital Morales Meseguer / Servicio de Rehabilitación (site 724005)

    Murcia

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

    Santander

  • Hospital Universitario La Fe (Site 724003)

    Valencia

Other trials in Spain

Sweden4 sites

  • Mälarsjukhuset, Dept. Of Neurology (site 752001)

    Eskilstuna

  • Dept. Of Neurology, Nyköping Hospital (site 752002)

    Nyköping

  • Östersunds Rehab Centrum (site 752004)

    Östersund

  • Läkarhuset Odenplan, Neuro Unit (site 752003)

    Stockholm

Other trials in Sweden

Denmark3 sites

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

    Aarhus

  • Herlev Hospital, Herlev Ringvej (Site 208004)

    Copenhagen

  • Neurologisk afdeling N, Amtssygehuset i Glostrup (Site 208003)

    Glostrup Municipality

Other trials in Denmark

Finland3 sites

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

    Jyväskylä

  • Invalidförbundets Rehabiliteringscenter i Lappland (Site 246004)

    Rovaniemi

  • Neurologiska Polikliniken, Tampere University Hospital (site 246001)

    Tampere

Other trials in Finland

Austria2 sites

  • NÖ LKH Grimmenstein-Hochegg (site 040002)

    Grimmenstein

  • Gaital-Kliniken Hermagor (site 040001)

    Hermagor

Other trials in Austria

Czechia2 sites

  • Faculty Hospital Brno (site 203002)

    Brno

  • Hospital Pardubice, Neurology dept. (site 203001)

    Pardubice

Other trials in Czechia

Malaysia2 sites

  • Hospital Kuala Lumpur (site 458002)

    Kuala Lumpur

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

    Kuala Lumpur

Other trials in Malaysia

Mexico2 sites

  • Colonia Ladrón de Guevara (Site 484001)

    Guadalajara, Jalisco

  • Angeles del Pedregal (Site 484002)

    México

Other trials in Mexico

Philippines2 sites

  • Perpetual Succour Hospital (site 608002)

    Cebu City

  • Metropolitan Medical Center (site 608001)

    Manila

Other trials in Philippines

Singapore2 sites

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

    Singapore

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

    Singapore

Other trials in Singapore

Taiwan2 sites

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

    Taichung

  • Veteran General Hospital (site 158001)

    Taipei

Other trials in Taiwan

Thailand2 sites

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

    Bangkok

  • Siriraj Hospital/Department of Rehabilitation Medicine (site 764001)

    Bangkok

Other trials in Thailand

China1 site

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

    Hong Kong

Other trials in China

About this study

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

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.

Medical subject headings
Muscle Spasticity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Around 3 to 5 months post injection

Secondary outcomes (3)

  1. Overall attainment of the treatment goals using the GAS T score

    Measured: Around 3 to 5 months post injection

  2. Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)

    Measured: Around 3 to 5 months post injection

  3. Global assessment of benefits by both the investigator and the subject (or guardian)

    Measured: Around 3 to 5 months post injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01020500
Sponsor's protocol ID
Y-79-52120-138
Acronym
ULIS2
Status last verified
Nov 2020
First submitted
24 Nov 2009
Last updated
6 Nov 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25856546

  • 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.

    PubMed 23794582

  • 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.

    PubMed 23512837

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle Spasticity, run by Ipsen at 96 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 sites in France, Germany, Russia, Australia, Italy and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01020500, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.

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