Clinical trial NCT04050527: Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Lower Limb Spasticity
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 438
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a primary diagnosis of unilateral adult lower limb nonprogressive focal spasticity

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Subject centred Goal Attainment Scaling Leg T score (GASleg T)
timeFrame: 16 months
Secondary outcomes:
measure: Muscle tone
timeFrame: 16 months
measure: Severity of different aspects of impairment
timeFrame: 16 months
measure: Total dose injected per cycle
timeFrame: 16 months
measure: Report muscles injected
timeFrame: 16 months
measure: Report dose per muscle
timeFrame: 16 months
measure: Assess correlations of subject centered goals
timeFrame: 16 months
measure: Evolution of Quality of Life
timeFrame: 16 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
state: California
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
city: Leawood
country: United States
facility: Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
state: Kansas
city: Foxboro
country: United States
facility: Neurology Center of NE,PC - Neurology
state: Massachusetts
city: Grosse Pointe
country: United States
facility: Beaumont Hospital, Grosse Pointe - Neurology
state: Michigan
city: Bronx
country: United States
facility: Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Cincinnati
country: United States
facility: Riverhills Healthcare
state: Ohio
city: Columbus
country: United States
facility: OrthoNeuro
state: Ohio
city: Allentown
country: United States
facility: Good Shepherd Rehabilitation Hospital - Neurology
state: Pennsylvania
city: Elkins Park
country: United States
facility: MossRehab - Einstein Medical Center
state: Pennsylvania
city: Paoli
country: United States
facility: Rehabilitation Associates - Neurology
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Salt Lake City
country: United States
facility: The University of Utah School of Medicine
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin - Froedtert Hospital
state: Wisconsin
city: Ipswich
country: Australia
facility: Princess Alexandra Hospital
city: Rozelle
country: Australia
facility: Royal Prince Alfred Hospital
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (HCFMRP) - Neurology
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto at Centro Integrado de Pesquisa (CIP) - Neurology
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
city: Fredericton
country: Canada
facility: River Valley Health - Stan Cassidy Foundation - Stan Cassidy
city: Montréal
country: Canada
facility: McGill University Health Center
city: Bordeau
country: France
facility: CHU - HÃ´pital Pellegrin - Neurologie
city: Garches
country: France
facility: CHU RAYMOND POINCARE - Neurology
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire (CHRU) de Lille - Hopital Pierre Swynghedauw - Neurology
city: Paris
country: France
facility: Höpital Sainte-Marie - Neurology
city: Reims
country: France
facility: Centre Hospitalier Universitaire De Reims - Hopital Maison B
city: Rennes
country: France
facility: Pole Saint Helier
city: Berlin
country: Germany
facility: Neurologie und Psychosomatik am Wittenbergplatz
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik
city: Luebeck
country: Germany
facility: Universitätsklinikum/Neurologie
city: Würzburg
country: Germany
facility: Neurologische Klinik und Poliklinik
city: Napoli
country: Italy
facility: Università Degli studi della Campania - Luigi Vanvitelli - Neurologica
city: Novara
country: Italy
facility: Istituto Scientifico di Riabilitazione di Veruno, Fondazione
city: Palermo
country: Italy
facility: PO Villa Sofia, AO Ospedali Riuniti Villa Sofia-Cervello
city: Roma
country: Italy
facility: AO S.Camillo-Forlanini
city: Verona
country: Italy
facility: Universita degli Studi di Verona - Centro di Ricerca in Riabilitazione Neuromotoria e Cognitiva (CRRNC) - Neurology
city: Kraków
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Warsaw
country: Poland
facility: Instytut Psychiatrii i Neurologii
city: Warsaw
country: Poland
facility: Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o. Brodnowskie Centrum Kliniczne Poliklinika Brodnowskiego Centrum Klinicznego
city: Wroclaw
country: Poland
facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu
city: Łódź
country: Poland
facility: Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi
city: Barnaul
country: Russian Federation
facility: Regional state budget health institution "City Hospital № 5"
city: Ekaterinburg
country: Russian Federation
facility: FGBOU VO "Ural state medical university"
city: Kazan
country: Russian Federation
facility: SAHI Interregional Clinical Diagnostic Center
city: Moscow
country: Russian Federation
facility: National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia
city: Saint Petersburg
country: Russian Federation
facility: Bekhterev National Research Medical Center for Psychiatry
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov First Saint-Petersburg State Medical University - Neurology
city: Saint-Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "All-Russian Center for Emergency Medicine and Medical Radiology named after A.M. Nikiforov" of the EMERCOM of Russia
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: