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

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ClinicalTrials.gov Identifier: NCT04050527
Recruitment Status : Completed
First Posted : August 8, 2019
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Adult Lower Limb Spasticity

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Study Type : Observational
Actual Enrollment : 438 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International, Multicentre, Observational, Prospective, Longitudinal Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)
Actual Study Start Date : December 19, 2019
Actual Primary Completion Date : July 29, 2022
Actual Study Completion Date : July 29, 2022



Primary Outcome Measures :
  1. Subject centred Goal Attainment Scaling Leg T score (GASleg T) [ Time Frame: 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 :
  1. Muscle tone [ Time Frame: 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).

  2. Severity of different aspects of impairment [ Time Frame: 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.

  3. Total dose injected per cycle [ Time Frame: 16 months ]
  4. Report muscles injected [ Time Frame: 16 months ]
  5. Report dose per muscle [ Time Frame: 16 months ]
  6. Assess correlations of subject centered goals [ Time Frame: 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.

  7. Evolution of Quality of Life [ Time Frame: 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".



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults with a primary diagnosis of unilateral adult lower limb nonprogressive focal spasticity
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050527


Locations
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Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT04050527    
Other Study ID Numbers: F-FR-52120-255
2018-004369-15 ( EudraCT Number )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases