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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Country [2] 0 0
Austria
State/province [2] 0 0
Hermagor
Country [3] 0 0
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
Country [12] 0 0
Denmark
State/province [12] 0 0
Glostrup
Country [13] 0 0
Finland
State/province [13] 0 0
Jyväskylä
Country [14] 0 0
Finland
State/province [14] 0 0
Rovaniemi
Country [15] 0 0
Finland
State/province [15] 0 0
Tampere
Country [16] 0 0
France
State/province [16] 0 0
Angers
Country [17] 0 0
France
State/province [17] 0 0
Argonay
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France
State/province [18] 0 0
Besançon
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France
State/province [19] 0 0
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
State/province [22] 0 0
Echirolles
Country [23] 0 0
France
State/province [23] 0 0
Garches
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Limoges
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
France
State/province [27] 0 0
Marseille
Country [28] 0 0
France
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Montpellier
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France
State/province [29] 0 0
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
State/province [32] 0 0
Rennes
Country [33] 0 0
France
State/province [33] 0 0
Strasbourg
Country [34] 0 0
France
State/province [34] 0 0
Toulouse
Country [35] 0 0
Germany
State/province [35] 0 0
Arnsdorf
Country [36] 0 0
Germany
State/province [36] 0 0
Beelitz
Country [37] 0 0
Germany
State/province [37] 0 0
Bennewitz
Country [38] 0 0
Germany
State/province [38] 0 0
Frankfurt
Country [39] 0 0
Germany
State/province [39] 0 0
Hannover
Country [40] 0 0
Germany
State/province [40] 0 0
Mannheim
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Germany
State/province [41] 0 0
Zwickau
Country [42] 0 0
Italy
State/province [42] 0 0
Ancona
Country [43] 0 0
Italy
State/province [43] 0 0
Ferrara
Country [44] 0 0
Italy
State/province [44] 0 0
Lecco
Country [45] 0 0
Italy
State/province [45] 0 0
Pietra Ligure
Country [46] 0 0
Italy
State/province [46] 0 0
Pisa
Country [47] 0 0
Italy
State/province [47] 0 0
Sarzana
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Daejeon
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Incheon
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Seoul
Country [51] 0 0
Malaysia
State/province [51] 0 0
Kuala Lumpur
Country [52] 0 0
Mexico
State/province [52] 0 0
Jalisco
Country [53] 0 0
Mexico
State/province [53] 0 0
México City
Country [54] 0 0
Philippines
State/province [54] 0 0
Cebu City
Country [55] 0 0
Philippines
State/province [55] 0 0
Manila
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Portugal
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Alcabideche
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Portugal
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Coimbra
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Portugal
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Faro
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Portugal
State/province [59] 0 0
Lisboa
Country [60] 0 0
Portugal
State/province [60] 0 0
Porto
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Chelyabinsk
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Russian Federation
State/province [62] 0 0
Kazan
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Krasnodar
Country [64] 0 0
Russian Federation
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Krasnoyarsk
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Moscow
Country [66] 0 0
Russian Federation
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Novosibirsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
St-Peterburg
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Singapore
State/province [68] 0 0
Singapore
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Spain
State/province [69] 0 0
Madrid
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Spain
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Murcia
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Spain
State/province [71] 0 0
Santander
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Spain
State/province [72] 0 0
Valencia
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Sweden
State/province [73] 0 0
Eskilstuna
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Sweden
State/province [74] 0 0
Nyköping
Country [75] 0 0
Sweden
State/province [75] 0 0
Stockholm
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Sweden
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Östersund
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Taiwan
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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
State/province [80] 0 0
Dewsbury
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United Kingdom
State/province [81] 0 0
Gillingham
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Lincoln
Country [83] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01020500