Adult Lower Limb SpasticityAboLiShNCT04050527
Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort
An observational study of Adult Lower Limb Spasticity, run by Ipsen at 51 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Lower Limb Spasticity
- How many people
- 438 participants
- Where
- 51 sitesin 9 countries
- Study dates
- 19 Dec 2019to 29 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a primary diagnosis of unilateral adult lower limb nonprogressive focal spasticity
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
51 sites in 9 countries.
51 sites in 9 countries
United States16 sites
Good Shepherd Rehabilitation Hospital - Neurology
Allentown, Pennsylvania, 18103
Dayton Center for Neurological Disorders
Centerville, Ohio, 45459
Riverhills Healthcare
Cincinnati, Ohio, 45212
OrthoNeuro
Columbus, Ohio, 43235
University of Texas Southwestern
Dallas, Texas, 75390
Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
Downey, California, 90242
MossRehab - Einstein Medical Center
Elkins Park, Pennsylvania, 19027
Neurology Center of NE,PC - Neurology
Foxborough, Massachusetts, 02035
Beaumont Hospital, Grosse Pointe - Neurology
Grosse Pointe, Michigan, 48230
Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
Leawood, Kansas, 10701
Medical College of Wisconsin - Froedtert Hospital
Milwaukee, Wisconsin, 53226-3522
Rehabilitation Associates - Neurology
Paoli, Pennsylvania, 19301
The University of Utah School of Medicine
Salt Lake City, Utah, 84132-0002
Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology
The Bronx, New York, 10467
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-0001
Russia7 sites
Regional state budget health institution "City Hospital № 5"
Barnaul, 656045
SAHI Interregional Clinical Diagnostic Center
Kazan'
National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia
Moscow, 125367
Bekhterev National Research Medical Center for Psychiatry
Saint Petersburg, 192019
Pavlov First Saint-Petersburg State Medical University - Neurology
Saint Petersburg, 197022
Federal State Budgetary Institution "All-Russian Center for Emergency Medicine and Medical Radiology named after A.M. Nikiforov" of the EMERCOM of Russia
Saint Petersburg, 197082
FGBOU VO "Ural state medical university"
Yekaterinburg, 620028
France6 sites
CHU - Hôpital Pellegrin - Neurologie
Bordeau, 33000
CHU RAYMOND POINCARE - Neurology
Garches, 92380
Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology
Lille, 59037
Höpital Sainte-Marie - Neurology
Paris, 75014
Centre Hospitalier Universitaire De Reims - Hopital Maison B
Reims, 51092
Pole Saint Helier
Rennes, 35043
Germany5 sites
Neurologie und Psychosomatik am Wittenbergplatz
Berlin, 10787
Universitätsklinikum Erlangen
Erlangen
Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik
Hanover, 30625
Universitätsklinikum/Neurologie
Lübeck
Neurologische Klinik und Poliklinik
Würzburg
Italy5 sites
Università Degli studi della Campania - Luigi Vanvitelli - Neurologica
Naples, 80131
Istituto Scientifico di Riabilitazione di Veruno, Fondazione
Novara, 28010
PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello
Palermo, 90146
AO S.Camillo-Forlanini
Roma, 00152
Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology
Verona, 37134
Poland5 sites
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, 31503
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi
Lodz, 93-513
Instytut Psychiatrii i Neurologii
Warsaw, 02957
Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego
Warsaw, 03-242
Wojewódzki Szpital Specjalistyczny we Wrocławiu
Wroclaw, 51-124
Canada3 sites
Glenrose Rehabilitation Hospital
Edmonton, T5G 0B7
River Valley Health - Stan Cassidy Foundation - Stan Cassidy
Fredericton, E3B0C7
McGill University Health Center
Montreal, H3G 1A4
Australia2 sites
Princess Alexandra Hospital
Ipswich, QLD 4102
Royal Prince Alfred Hospital
Rozelle, 2039
Brazil2 sites
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology
Ribeirão Preto, 14049-900
Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology
São José do Rio Preto, 15091-240
About this study
Official 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)
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.
- Conditions
- Adult Lower Limb Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject centred Goal Attainment Scaling Leg T score (GASleg T)
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]
Measured: 16 months
Secondary outcomes (7)
Muscle tone
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).
Measured: 16 months
Severity of different aspects of impairment
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.
Measured: 16 months
Total dose injected per cycle
Measured: 16 months
Report muscles injected
Measured: 16 months
Report dose per muscle
Measured: 16 months
Assess correlations of subject centered goals
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.
Measured: 16 months
Evolution of Quality of Life
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".
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start19 Dec 2019
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adult Lower Limb SpasticityStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050527
- Sponsor's protocol ID
- F-FR-52120-255
- Other IDs
- 2018-004369-15, 2018
- Acronym
- AboLiSh
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Esquenazi A, Zorowitz RD, Ashford S, Jacinto J, Beneteau M, Maisonobe P, Hannes C, Sandars S. Achieving treatment goals with repeated injections of botulinum toxin in adults with leg spasticity. Curr Med Res Opin. 2025 Dec;41(12):2277-2285. doi: 10.1080/03007995.2025.2606555. Epub 2025 Dec 25.
PubMed 41449804Esquenazi A, Zorowitz RD, Ashford S, Beneteau M, Maisonobe P, Hannes C, Jacinto J; AboLiSh Study Group. Longitudinal Goal Attainment With Repeat Injections of AbobotulinumtoxinA in Adults With Lower Limb Spasticity: Results From a Prospective Observational Study. Arch Phys Med Rehabil. 2025 Jun;106(6):894-901. doi: 10.1016/j.apmr.2024.10.017. Epub 2024 Nov 20.
PubMed 39571744Esquenazi A, Zorowitz RD, Ashford S, Maisonobe P, Page S, Jacinto J. Clinical presentation of patients with lower limb spasticity undergoing routine treatment with botulinum toxin: baseline findings from an international observational study. J Rehabil Med. 2023 Oct 5;55:jrm4257. doi: 10.2340/jrm.v55.4257.
PubMed 37794845
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT04050527
- Acronym / sponsor ID
- AboLiSh / F-FR-52120-255
- Conditions
- Adult Lower Limb Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a primary diagnosis of unilateral adult lower limb nonprogressive focal spasticity
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subject centred Goal Attainment Scaling Leg T score (GASleg T)
Time frame: 16 months
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]
7 secondary outcomes
Muscle tone
Time frame: 16 months
Severity of different aspects of impairment
Time frame: 16 months
Total dose injected per cycle
Time frame: 16 months
Report muscles injected
Time frame: 16 months
Report dose per muscle
Time frame: 16 months
Assess correlations of subject centered goals
Time frame: 16 months
Evolution of Quality of Life
Time frame: 16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 41449804Esquenazi A, Zorowitz RD, Ashford S, Jacinto J, Beneteau M, Maisonobe P, Hannes C, Sandars S. Achieving treatment goals with repeated injections of botulinum toxin in adults with leg spasticity. Curr Med Res Opin. 2025 Dec;41(12):2277-2285. doi: 10.1080/03007995.2025.2606555. Epub 2025 Dec 25.
- Derived from this study: PubMed 39571744Esquenazi A, Zorowitz RD, Ashford S, Beneteau M, Maisonobe P, Hannes C, Jacinto J; AboLiSh Study Group. Longitudinal Goal Attainment With Repeat Injections of AbobotulinumtoxinA in Adults With Lower Limb Spasticity: Results From a Prospective Observational Study. Arch Phys Med Rehabil. 2025 Jun;106(6):894-901. doi: 10.1016/j.apmr.2024.10.017. Epub 2024 Nov 20.
- Derived from this study: PubMed 37794845Esquenazi A, Zorowitz RD, Ashford S, Maisonobe P, Page S, Jacinto J. Clinical presentation of patients with lower limb spasticity undergoing routine treatment with botulinum toxin: baseline findings from an international observational study. J Rehabil Med. 2023 Oct 5;55:jrm4257. doi: 10.2340/jrm.v55.4257.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
51 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult Lower Limb Spasticity, run by Ipsen at 51 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Russia, France, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject centred Goal Attainment Scaling Leg T score (GASleg T) (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04050527, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.