Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)

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.

Study Overview

• Status: Completed
• Conditions: Adult Lower Limb Spasticity

• Study Type: Observational
• Enrollment (Actual): 438

Contacts and Locations

Study Locations

• Australia
  • Ipswich, Australia, QLD 4102
    • Princess Alexandra Hospital
  • Rozelle, Australia, 2039
    • Royal Prince Alfred Hospital
• Brazil
  • Ribeirão Preto, Brazil, 14049-900
    • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology
  • São José Do Rio Preto, Brazil, 15091-240
    • Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology
• Canada
  • Edmonton, Canada, T5G 0B7
    • Glenrose Rehabilitation Hospital
  • Fredericton, Canada, E3B0C7
    • River Valley Health - Stan Cassidy Foundation - Stan Cassidy
  • Montréal, Canada, H3G 1A4
    • McGill University Health Center
• France
  • Bordeau, France, 33000
    • CHU - Hôpital Pellegrin - Neurologie
  • Garches, France, 92380
    • CHU RAYMOND POINCARE - Neurology
  • Lille, France, 59037
    • Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology
  • Paris, France, 75014
    • Höpital Sainte-Marie - Neurology
  • Reims, France, 51092
    • Centre Hospitalier Universitaire De Reims - Hopital Maison B
  • Rennes, France, 35043
    • Pole Saint Helier
• Germany
  • Berlin, Germany, 10787
    • Neurologie und Psychosomatik am Wittenbergplatz
  • Erlangen, Germany
    • Universitätsklinikum Erlangen
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik
  • Luebeck, Germany
    • Universitätsklinikum/Neurologie
  • Würzburg, Germany
    • Neurologische Klinik und Poliklinik
• Italy
  • Napoli, Italy, 80131
    • Università Degli studi della Campania - Luigi Vanvitelli - Neurologica
  • Novara, Italy, 28010
    • Istituto Scientifico di Riabilitazione di Veruno, Fondazione
  • Palermo, Italy, 90146
    • PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello
  • Roma, Italy, 00152
    • AO S.Camillo-Forlanini
  • Verona, Italy, 37134
    • Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology
• Poland
  • Kraków, Poland, 31503
    • SP ZOZ Szpital Uniwersytecki w Krakowie
  • Warsaw, Poland, 02957
    • Instytut Psychiatrii i Neurologii
  • Warsaw, Poland, 03-242
    • Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego
  • Wroclaw, Poland, 51-124
    • Wojewódzki Szpital Specjalistyczny we Wrocławiu
  • Łódź, Poland, 93-513
    • Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • Regional state budget health institution "City Hospital № 5"
  • Ekaterinburg, Russian Federation, 620028
    • FGBOU VO "Ural state medical university"
  • Kazan, Russian Federation
    • SAHI Interregional Clinical Diagnostic Center
  • Moscow, Russian Federation, 125367
    • National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia
  • Saint Petersburg, Russian Federation, 192019
    • Bekhterev National Research Medical Center for Psychiatry
  • Saint-Petersburg, Russian Federation, 197022
    • Pavlov First Saint-Petersburg State Medical University - Neurology
  • Saint-Petersburg, Russian Federation, 197082
    • Federal State Budgetary Institution "All-Russian Center for Emergency Medicine and Medical Radiology named after A.M. Nikiforov" of the EMERCOM of Russia
• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar National Rehabilitation Hospital
  • Kansas
    • Leawood, Kansas, United States, 10701
      • Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
  • Massachusetts
    • Foxboro, Massachusetts, United States, 02035
      • Neurology Center of NE,PC - Neurology
  • Michigan
    • Grosse Pointe, Michigan, United States, 48230
      • Beaumont Hospital, Grosse Pointe - Neurology
  • New York
    • Bronx, New York, United States, 10467
      • Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Dayton Center for Neurological Disorders
    • Cincinnati, Ohio, United States, 45212
      • Riverhills Healthcare
    • Columbus, Ohio, United States, 43235
      • OrthoNeuro
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Good Shepherd Rehabilitation Hospital - Neurology
    • Elkins Park, Pennsylvania, United States, 19027
      • MossRehab - Einstein Medical Center
    • Paoli, Pennsylvania, United States, 19301
      • Rehabilitation Associates - Neurology
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84132-0002
      • The University of Utah School of Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Medical College of Wisconsin - Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults with a primary diagnosis of unilateral adult lower limb nonprogressive focal spasticity

Description

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.

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	16 months
Total dose injected per cycle		16 months
Report muscles injected		16 months
Report dose per muscle		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.	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".	16 months

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): July 29, 2022
• Study Completion (Actual): July 29, 2022

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: F-FR-52120-255; 2018-004369-15 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No