Status:
COMPLETED
Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort
Lead Sponsor:
Ipsen
Conditions:
Adult Lower Limb Spasticity
Eligibility:
All Genders
18+ years
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 lim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 29 2022
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT04050527
Start Date
December 19 2019
End Date
July 29 2022
Last Update
August 5 2022
Active Locations (51)
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1
Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology
Downey, California, United States, 90242
2
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010
3
Kansas City Bone and Joint Clinic, P.A. (KCBJ) - Overland Pa
Leawood, Kansas, United States, 10701
4
Neurology Center of NE,PC - Neurology
Foxborough, Massachusetts, United States, 02035