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

Completed

• Conditions: Adult Lower Limb Spasticity

• Registration Number: NCT04050527
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Study Start: 2019-12-19
• Primary Completion: 2022-07-29
• Study Completion: 2022-07-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject centred Goal Attainment Scaling Leg T score (GASleg T)	16 months	Mean individual GASleg T score. Goal attainment for each goal will be recorded clinically on a 5-point verbal rating scale (range -2 to +2) and goal scores combined to give an aggregated T score using a standard formula (GASleg T score). Range meaning is -2 = much less than expected and +2 = much more than expected.; The subject and/or caregiver to identify the main goal areas and establish agreed person centred and function related goals guided by GASleg (usually one primary and up to two secondary goals) at each visit. Goal attainment will be evaluated at the routine follow up visit.; Goals will be redefined and/or newly set at each injection visit or as per routine practice if further injections are not given. Goals will be SMART \[Specific, measurable, attainable, relevant, and time-based\]

Secondary Outcome Measures

Name	Time	Method
Muscle tone	16 months	Muscle tone will be evaluated using the Modified Ashworth Scale (MAS) /Tardieu Scale according to clinical practice. The MAS is a six point scale (with available scores of 0, 1, 1+, 2, 3 and 4) reporting changes in muscle tone during muscle flexion or extension. Tardieu scale quantifies muscle spasticity by assessing the response of the muscle to stretch applied at specified velocities. It can therefore broadly differentiate between the two key factors explaining resistance to passive stretch, namely contracture (non-neural factors) and spasticity (neural factors).
Assess correlations of subject centered goals	16 months	Correlations of subject centred goals and related standardised rating scales will be assessed using GASleg and standardised outcome measures selected according to the goals for treatment.
Total dose injected per cycle	16 months
Report dose per muscle	16 months
Severity of different aspects of impairment	16 months	Severity of different aspects of impairment in subjects with neurological injury will be evaluated using the Lower Limb Spasticity adapted Neurological Impairment Scale. (LLS-NIS) Higher LLS-NIS scores indicate more severe impairment (LLS-NIS). Higher LLS-NIS scores indicate more severe impairment.
Report muscles injected	16 months
Evolution of Quality of Life	16 months	Assess the evolution of QoL at each visit based on the EQ-5D-5L and the QoL element of LegA. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem".

Trial Locations

Locations (51)

Rancho Los Amigos National Rehabilitation Center (RLANRC) - Neurology; 🇺🇸 Downey, California, United States

MedStar National Rehabilitation Hospital; 🇺🇸 Washington, 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; 🇺🇸 Foxboro, 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; 🇺🇸 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

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