Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04050527
Registration number
NCT04050527
Ethics application status
Date submitted
1/08/2019
Date registered
8/08/2019
Date last updated
5/08/2022
Titles & IDs
Public title
Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort
Query!
Scientific title
International, Multicentre, Observational, Prospective, Longitudinal Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)
Query!
Secondary ID [1]
0
0
2018-004369-15
Query!
Secondary ID [2]
0
0
F-FR-52120-255
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
AboLiSh
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Adult Lower Limb Spasticity
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Subject centred Goal Attainment Scaling Leg T score (GASleg T)
Query!
Assessment method [1]
0
0
Mean individual GASleg T score. Goal attainment for each goal will be recorded clinically on a 5-point verbal rating scale (range -2 to +2) and goal scores combined to give an aggregated T score using a standard formula (GASleg T score). Range meaning is -2 = much less than expected and +2 = much more than expected.
The subject and/or caregiver to identify the main goal areas and establish agreed person centred and function related goals guided by GASleg (usually one primary and up to two secondary goals) at each visit. Goal attainment will be evaluated at the routine follow up visit.
Goals will be redefined and/or newly set at each injection visit or as per routine practice if further injections are not given. Goals will be SMART \[Specific, measurable, attainable, relevant, and time-based\]
Query!
Timepoint [1]
0
0
16 months
Query!
Secondary outcome [1]
0
0
Muscle tone
Query!
Assessment method [1]
0
0
Muscle tone will be evaluated using the Modified Ashworth Scale (MAS) /Tardieu Scale according to clinical practice. The MAS is a six point scale (with available scores of 0, 1, 1+, 2, 3 and 4) reporting changes in muscle tone during muscle flexion or extension. Tardieu scale quantifies muscle spasticity by assessing the response of the muscle to stretch applied at specified velocities. It can therefore broadly differentiate between the two key factors explaining resistance to passive stretch, namely contracture (non-neural factors) and spasticity (neural factors).
Query!
Timepoint [1]
0
0
16 months
Query!
Secondary outcome [2]
0
0
Severity of different aspects of impairment
Query!
Assessment method [2]
0
0
Severity of different aspects of impairment in subjects with neurological injury will be evaluated using the Lower Limb Spasticity adapted Neurological Impairment Scale. (LLS-NIS) Higher LLS-NIS scores indicate more severe impairment (LLS-NIS). Higher LLS-NIS scores indicate more severe impairment.
Query!
Timepoint [2]
0
0
16 months
Query!
Secondary outcome [3]
0
0
Total dose injected per cycle
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
16 months
Query!
Secondary outcome [4]
0
0
Report muscles injected
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
16 months
Query!
Secondary outcome [5]
0
0
Report dose per muscle
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
16 months
Query!
Secondary outcome [6]
0
0
Assess correlations of subject centered goals
Query!
Assessment method [6]
0
0
Correlations of subject centred goals and related standardised rating scales will be assessed using GASleg and standardised outcome measures selected according to the goals for treatment.
Query!
Timepoint [6]
0
0
16 months
Query!
Secondary outcome [7]
0
0
Evolution of Quality of Life
Query!
Assessment method [7]
0
0
Assess the evolution of QoL at each visit based on the EQ-5D-5L and the QoL element of LegA. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem".
Query!
Timepoint [7]
0
0
16 months
Query!
Eligibility
Key inclusion criteria
* Adult male and female subjects =18 years of age
* Primary diagnosis with unilateral adult lower limb nonprogressive spasticity.
* Subject able to take more than five steps with or without assistance.
* Decision to treat the lower limb with aboBoNT-A by the care provider made prior to, and independently from, the decision to enroll the subject in the observational study as per country label.
* Previously untreated with BoNT-A (i.e. naïve to BoNT-A), or previously treated with a BoNT-A (i.e. non-naïve to BoNT-A). For those who were previously treated with BoNTA, they should have responded to BoNT-A treatment and at least 12 weeks should have elapsed from prior injection.
* Signed informed consent prior to participation in the study.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Prior history of nonresponsiveness to BoNT-A therapy
* Previous treatment with BoNT-A of less than 12 weeks prior to enrolment in study.
* Current participation in any other clinical study or have participated within the 12 weeks prior to the Inclusion visit (Visit 1) of this study.
* Severe limitations in passive range of motion/contractures in the affected limb (MAS=4 in at least one of the joints in the lower limb).
* Limb surgery or intrathecal baclofen therapy placement for spasticity within 3 months.
* Nonambulatory subject.
* Pregnant and lactating women.
* Progressive neurological conditions or diagnosis of cerebral palsy.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
19/12/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/07/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
438
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Princess Alexandra Hospital - Ipswich
Query!
Recruitment hospital [2]
0
0
Royal Prince Alfred Hospital - Rozelle
Query!
Recruitment postcode(s) [1]
0
0
QLD 4102 - Ipswich
Query!
Recruitment postcode(s) [2]
0
0
2039 - Rozelle
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Kansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Massachusetts
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Pennsylvania
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Utah
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Wisconsin
Query!
Country [13]
0
0
Brazil
Query!
State/province [13]
0
0
Ribeirão Preto
Query!
Country [14]
0
0
Brazil
Query!
State/province [14]
0
0
São José Do Rio Preto
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Edmonton
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Fredericton
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Montréal
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Bordeau
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Garches
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Lille
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Paris
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Reims
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Rennes
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Berlin
Query!
Country [25]
0
0
Germany
Query!
State/province [25]
0
0
Erlangen
Query!
Country [26]
0
0
Germany
Query!
State/province [26]
0
0
Hannover
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Luebeck
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Würzburg
Query!
Country [29]
0
0
Italy
Query!
State/province [29]
0
0
Napoli
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Novara
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Palermo
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Roma
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Verona
Query!
Country [34]
0
0
Poland
Query!
State/province [34]
0
0
Kraków
Query!
Country [35]
0
0
Poland
Query!
State/province [35]
0
0
Warsaw
Query!
Country [36]
0
0
Poland
Query!
State/province [36]
0
0
Wroclaw
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Lódz
Query!
Country [38]
0
0
Russian Federation
Query!
State/province [38]
0
0
Barnaul
Query!
Country [39]
0
0
Russian Federation
Query!
State/province [39]
0
0
Ekaterinburg
Query!
Country [40]
0
0
Russian Federation
Query!
State/province [40]
0
0
Kazan
Query!
Country [41]
0
0
Russian Federation
Query!
State/province [41]
0
0
Moscow
Query!
Country [42]
0
0
Russian Federation
Query!
State/province [42]
0
0
Saint Petersburg
Query!
Country [43]
0
0
Russian Federation
Query!
State/province [43]
0
0
Saint-Petersburg
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Ipsen
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04050527
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Ipsen Medical Director
Query!
Address
0
0
Ipsen
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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/NCT04050527
Download to PDF