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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

More Details

Status
Completed
Sponsor
Ipsen

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.