Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/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
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)
Secondary ID [1] 0 0
2018-004369-15
Secondary ID [2] 0 0
F-FR-52120-255
Universal Trial Number (UTN)
Trial acronym
AboLiSh
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adult Lower Limb 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
Subject centred Goal Attainment Scaling Leg T score (GASleg T)
Timepoint [1] 0 0
16 months
Secondary outcome [1] 0 0
Muscle tone
Timepoint [1] 0 0
16 months
Secondary outcome [2] 0 0
Severity of different aspects of impairment
Timepoint [2] 0 0
16 months
Secondary outcome [3] 0 0
Total dose injected per cycle
Timepoint [3] 0 0
16 months
Secondary outcome [4] 0 0
Report muscles injected
Timepoint [4] 0 0
16 months
Secondary outcome [5] 0 0
Report dose per muscle
Timepoint [5] 0 0
16 months
Secondary outcome [6] 0 0
Assess correlations of subject centered goals
Timepoint [6] 0 0
16 months
Secondary outcome [7] 0 0
Evolution of Quality of Life
Timepoint [7] 0 0
16 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
19/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/07/2022
Sample size
Target
Accrual to date
Final
438
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Ipswich
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Rozelle
Recruitment postcode(s) [1] 0 0
QLD 4102 - Ipswich
Recruitment postcode(s) [2] 0 0
2039 - Rozelle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Brazil
State/province [13] 0 0
Ribeirão Preto
Country [14] 0 0
Brazil
State/province [14] 0 0
São José Do Rio Preto
Country [15] 0 0
Canada
State/province [15] 0 0
Edmonton
Country [16] 0 0
Canada
State/province [16] 0 0
Fredericton
Country [17] 0 0
Canada
State/province [17] 0 0
Montréal
Country [18] 0 0
France
State/province [18] 0 0
Bordeau
Country [19] 0 0
France
State/province [19] 0 0
Garches
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
France
State/province [21] 0 0
Paris
Country [22] 0 0
France
State/province [22] 0 0
Reims
Country [23] 0 0
France
State/province [23] 0 0
Rennes
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Erlangen
Country [26] 0 0
Germany
State/province [26] 0 0
Hannover
Country [27] 0 0
Germany
State/province [27] 0 0
Luebeck
Country [28] 0 0
Germany
State/province [28] 0 0
Würzburg
Country [29] 0 0
Italy
State/province [29] 0 0
Napoli
Country [30] 0 0
Italy
State/province [30] 0 0
Novara
Country [31] 0 0
Italy
State/province [31] 0 0
Palermo
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Italy
State/province [33] 0 0
Verona
Country [34] 0 0
Poland
State/province [34] 0 0
Kraków
Country [35] 0 0
Poland
State/province [35] 0 0
Warsaw
Country [36] 0 0
Poland
State/province [36] 0 0
Wroclaw
Country [37] 0 0
Poland
State/province [37] 0 0
Lódz
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Barnaul
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Ekaterinburg
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Kazan
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Moscow
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Saint Petersburg
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Saint-Petersburg

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04050527
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical 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/study/NCT04050527