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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