Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [18] 0 0
France
State/province [18] 0 0
Besançon
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux
Country [20] 0 0
France
State/province [20] 0 0
Coubert
Country [21] 0 0
France
State/province [21] 0 0
Créteil
Country [22] 0 0
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
State/province [28] 0 0
Montpellier
Country [29] 0 0
France
State/province [29] 0 0
Nantes
Country [30] 0 0
France
State/province [30] 0 0
Paris
Country [31] 0 0
France
State/province [31] 0 0
Reims Cedex
Country [32] 0 0
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
Country [41] 0 0
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
Country [56] 0 0
Portugal
State/province [56] 0 0
Alcabideche
Country [57] 0 0
Portugal
State/province [57] 0 0
Coimbra
Country [58] 0 0
Portugal
State/province [58] 0 0
Faro
Country [59] 0 0
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
Country [62] 0 0
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
State/province [64] 0 0
Krasnoyarsk
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Moscow
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Novosibirsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
St-Peterburg
Country [68] 0 0
Singapore
State/province [68] 0 0
Singapore
Country [69] 0 0
Spain
State/province [69] 0 0
Madrid
Country [70] 0 0
Spain
State/province [70] 0 0
Murcia
Country [71] 0 0
Spain
State/province [71] 0 0
Santander
Country [72] 0 0
Spain
State/province [72] 0 0
Valencia
Country [73] 0 0
Sweden
State/province [73] 0 0
Eskilstuna
Country [74] 0 0
Sweden
State/province [74] 0 0
Nyköping
Country [75] 0 0
Sweden
State/province [75] 0 0
Stockholm
Country [76] 0 0
Sweden
State/province [76] 0 0
Östersund
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taichung
Country [78] 0 0
Taiwan
State/province [78] 0 0
Taipei
Country [79] 0 0
Thailand
State/province [79] 0 0
Bangkok
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Dewsbury
Country [81] 0 0
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