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

Completed

Conditions studied: Adult Lower Limb Spasticity

In brief

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.

Key facts

Study ID

NCT04050527

Run by

Ipsen

People needed

438

Starts

2019-12-19

Expected to finish

2022-07-29

Last updated by the study team

2022-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology — Downey, California, United States

Full record on ClinicalTrials.gov

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