Adult Lower Limb Spasticity Clinical Trial
— AboLiShOfficial 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)
| Verified date | August 2022 |
| Source | Ipsen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 438 |
| Est. completion date | July 29, 2022 |
| Est. primary completion date | July 29, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Princess Alexandra Hospital | Ipswich | |
| Australia | Royal Prince Alfred Hospital | Rozelle | |
| Brazil | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology | Ribeirão Preto | |
| Brazil | Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology | São José Do Rio Preto | |
| Canada | Glenrose Rehabilitation Hospital | Edmonton | |
| Canada | River Valley Health - Stan Cassidy Foundation - Stan Cassidy | Fredericton | |
| Canada | McGill University Health Center | Montréal | |
| France | CHU - Hôpital Pellegrin - Neurologie | Bordeau | |
| France | CHU RAYMOND POINCARE - Neurology | Garches | |
| France | Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology | Lille | |
| France | Höpital Sainte-Marie - Neurology | Paris | |
| France | Centre Hospitalier Universitaire De Reims - Hopital Maison B | Reims | |
| France | Pole Saint Helier | Rennes | |
| Germany | Neurologie und Psychosomatik am Wittenbergplatz | Berlin | |
| Germany | Universitätsklinikum Erlangen | Erlangen | |
| Germany | Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik | Hannover | |
| Germany | Universitätsklinikum/Neurologie | Luebeck | |
| Germany | Neurologische Klinik und Poliklinik | Würzburg | |
| Italy | Università Degli studi della Campania - Luigi Vanvitelli - Neurologica | Napoli | |
| Italy | Istituto Scientifico di Riabilitazione di Veruno, Fondazione | Novara | |
| Italy | PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello | Palermo | |
| Italy | AO S.Camillo-Forlanini | Roma | |
| Italy | Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology | Verona | |
| Poland | SP ZOZ Szpital Uniwersytecki w Krakowie | Kraków | |
| Poland | Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi | Lódz | |
| Poland | Instytut Psychiatrii i Neurologii | Warsaw | |
| Poland | Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego | Warsaw | |
| Poland | Wojewódzki Szpital Specjalistyczny we Wroclawiu | Wroclaw | |
| Russian Federation | Regional state budget health institution "City Hospital ? 5" | Barnaul | |
| Russian Federation | FGBOU VO "Ural state medical university" | Ekaterinburg | |
| Russian Federation | SAHI Interregional Clinical Diagnostic Center | Kazan | |
| Russian Federation | National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia | Moscow | |
| Russian Federation | Bekhterev National Research Medical Center for Psychiatry | Saint Petersburg | |
| Russian Federation | 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 | |
| Russian Federation | Pavlov First Saint-Petersburg State Medical University - Neurology | Saint-Petersburg | |
| United States | Good Shepherd Rehabilitation Hospital - Neurology | Allentown | Pennsylvania |
| United States | Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology | Bronx | New York |
| United States | Dayton Center for Neurological Disorders | Centerville | Ohio |
| United States | Riverhills Healthcare | Cincinnati | Ohio |
| United States | OrthoNeuro | Columbus | Ohio |
| United States | University of Texas Southwestern | Dallas | Texas |
| United States | Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology | Downey | California |
| United States | MossRehab - Einstein Medical Center | Elkins Park | Pennsylvania |
| United States | Neurology Center of NE,PC - Neurology | Foxboro | Massachusetts |
| United States | Beaumont Hospital, Grosse Pointe - Neurology | Grosse Pointe | Michigan |
| United States | Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa | Leawood | Kansas |
| United States | Medical College of Wisconsin - Froedtert Hospital | Milwaukee | Wisconsin |
| United States | Rehabilitation Associates - Neurology | Paoli | Pennsylvania |
| United States | The University of Utah School of Medicine | Salt Lake City | Utah |
| United States | MedStar National Rehabilitation Hospital | Washington | District of Columbia |
| United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Ipsen |
United States, Australia, Brazil, Canada, France, Germany, Italy, Poland, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | Total dose injected per cycle | 16 months | ||
| Secondary | Report muscles injected | 16 months | ||
| Secondary | Report dose per muscle | 16 months | ||
| Secondary | 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 | |
| Secondary | 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 |