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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01020500




Registration number
NCT01020500
Ethics application status
Date submitted
24/11/2009
Date registered
25/11/2009
Date last updated
6/11/2020

Titles & IDs
Public title
To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke
Scientific 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
Secondary ID [1] 0 0
Y-79-52120-138
Universal Trial Number (UTN)
Trial acronym
ULIS2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle Spasticity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Around 3 to 5 months post injection
Secondary outcome [1] 0 0
Overall attainment of the treatment goals using the GAS T score
Timepoint [1] 0 0
Around 3 to 5 months post injection
Secondary outcome [2] 0 0
Result of standardized outcome measures (e.g., muscle tone reduction, pain scores, arm function test)
Timepoint [2] 0 0
Around 3 to 5 months post injection
Secondary outcome [3] 0 0
Global assessment of benefits by both the investigator and the subject (or guardian)
Timepoint [3] 0 0
Around 3 to 5 months post injection

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Contraindications to any BoNT-A preparations

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
469
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Rankin Park (site 036006) - Newcastle
Recruitment hospital [2] 0 0
Northshore Private Hospital (site 036003) - Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital (site 036005) - Sydney
Recruitment hospital [4] 0 0
Ryde Rehabilitation Center (site 036002) - Sydney
Recruitment hospital [5] 0 0
St Joseph's Hospital (site 036004) - Sydney
Recruitment hospital [6] 0 0
St Vincent's Hospital (site 036001) - Sydney
Recruitment postcode(s) [1] 0 0
- Newcastle
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Grimmenstein
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Austria
State/province [2] 0 0
Hermagor
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Belgium
State/province [3] 0 0
Antwerpen
Country [4] 0 0
Belgium
State/province [4] 0 0
Brugge
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Yvoir
Country [7] 0 0
China
State/province [7] 0 0
Hong Kong
Country [8] 0 0
Czechia
State/province [8] 0 0
Brno
Country [9] 0 0
Czechia
State/province [9] 0 0
Pardubice
Country [10] 0 0
Denmark
State/province [10] 0 0
Aarhus
Country [11] 0 0
Denmark
State/province [11] 0 0
Copenhagen
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Denmark
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Glostrup
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Finland
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Jyväskylä
Country [14] 0 0
Finland
State/province [14] 0 0
Rovaniemi
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Finland
State/province [15] 0 0
Tampere
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France
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Angers
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France
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Argonay
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France
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Besançon
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France
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Bordeaux
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France
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Coubert
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France
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Créteil
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France
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Echirolles
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France
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Garches
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France
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Lille
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France
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Limoges
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France
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Lyon
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France
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Marseille
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France
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Montpellier
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France
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Nantes
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France
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Paris
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France
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Reims Cedex
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France
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Rennes
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France
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Strasbourg
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France
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Toulouse
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Germany
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Arnsdorf
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Germany
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Beelitz
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Germany
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Bennewitz
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Germany
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Frankfurt
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Germany
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Hannover
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Germany
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Mannheim
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Germany
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Zwickau
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Italy
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Ancona
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Italy
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Ferrara
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Italy
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Lecco
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Italy
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Pietra Ligure
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Italy
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Pisa
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Italy
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Sarzana
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Malaysia
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Kuala Lumpur
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Mexico
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Jalisco
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Mexico
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México City
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Philippines
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Cebu City
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Philippines
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Manila
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Portugal
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Coimbra
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Faro
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Portugal
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Lisboa
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Portugal
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Porto
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Krasnodar
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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St-Peterburg
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Singapore
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Singapore
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Spain
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Madrid
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Murcia
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Santander
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Valencia
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Sweden
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Eskilstuna
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Nyköping
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Stockholm
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Sweden
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Östersund
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Taichung
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Taiwan
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Taipei
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Thailand
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Bangkok
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United Kingdom
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Dewsbury
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United Kingdom
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Gillingham
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United Kingdom
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Lincoln
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United Kingdom
State/province [83] 0 0
Middlesex
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01020500
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Study Director
Address 0 0
Ipsen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01020500