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

Ipsen

Status: Completed

Conditions: Adult Lower Limb Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT04050527

2018-004369-15 (EudraCT Number)

F-FR-52120-255

Details and patient eligibility

About

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.

Enrollment: 438 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.