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

NCT ID: NCT04050527

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 438 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-19
• Study Completion Date: 2022-07-29

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.

Conditions

Adult Lower Limb Spasticity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology

Downey, California, United States

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa

Leawood, Kansas, United States

Neurology Center of NE,PC - Neurology

Foxborough, Massachusetts, United States

Beaumont Hospital, Grosse Pointe - Neurology

Grosse Pointe, Michigan, United States

Yeshiva University - Albert Einstein College of Medicine - Montefiore Medical Center (MMC) - Neurology

The Bronx, New York, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

Dayton Center for Neurological Disorders

Centerville, Ohio, United States

Riverhills Healthcare

Cincinnati, Ohio, United States

OrthoNeuro

Columbus, Ohio, United States

Good Shepherd Rehabilitation Hospital - Neurology

Allentown, Pennsylvania, United States

MossRehab - Einstein Medical Center

Elkins Park, Pennsylvania, United States

Rehabilitation Associates - Neurology

Paoli, Pennsylvania, United States

University of Texas Southwestern

Dallas, Texas, United States

The University of Utah School of Medicine

Salt Lake City, Utah, United States

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, United States

Princess Alexandra Hospital

Ipswich, , Australia

Royal Prince Alfred Hospital

Rozelle, , Australia

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, , Brazil

Glenrose Rehabilitation Hospital

Edmonton, , Canada

River Valley Health - Stan Cassidy Foundation - Stan Cassidy

Fredericton, , Canada

McGill University Health Center

Montreal, , Canada

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, , France

Neurologie und Psychosomatik am Wittenbergplatz

Berlin, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Medizinische Hochschule Hannover - Neurology Neurologische Poliklinik

Hanover, , Germany

Universitätsklinikum/Neurologie

Lübeck, , Germany

Neurologische Klinik und Poliklinik

Würzburg, , Germany

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, , Italy

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika w Lodzi

Lodz, , 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 Wrocławiu

Wroclaw, , Poland

Regional state budget health institution "City Hospital № 5"

Barnaul, , Russia

SAHI Interregional Clinical Diagnostic Center

Kazan', , Russia

National Medical Research Treatment and Rehabilitation Center of the Ministry of Health of Russia

Moscow, , Russia

Bekhterev National Research Medical Center for Psychiatry

Saint Petersburg, , Russia

Pavlov First Saint-Petersburg State Medical University - Neurology

Saint Petersburg, , Russia

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, , Russia

FGBOU VO "Ural state medical university"

Yekaterinburg, , Russia

Countries

United States; Australia; Brazil; Canada; France; Germany; Italy; Poland; Russia

References

Esquenazi 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.

Reference Type: DERIVED

PMID: 39571744 (View on PubMed)

Esquenazi 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.

Reference Type: DERIVED

PMID: 37794845 (View on PubMed)

Other Identifiers

2018-004369-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

F-FR-52120-255

Identifier Type: -

Identifier Source: org_study_id