Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity

December 17, 2020 updated by: Ipsen

A Phase IV, Prospective, Observational, Multicentre Study Evaluating the Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity.

The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following repeated injection cycles where they occur) alongside spasticity management used in real life settings over a period of 18 months (and a maximum of six injection cycles).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
242

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital
      • North Palm Beach, Florida, United States, 33408
        • Laszlo J. Mate, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Clinical Integrative Research Central Atlanta
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Mt. Washington Pediatric Hospital
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital Pediatric Research
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Gillette Children's Specialty Healthcare
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Valley Health System
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children's Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Dayton, Ohio, United States, 45404
        • Dayton Children's Hospital
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • The Children's Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Shriners Hospitals for Children
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Good Shepherd Rehabilitation Network
      • Philadelphia, Pennsylvania, United States, 19140
        • Shriners Hospitals for Children
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Shriners Hospitals for Children
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Children's Hospital at Erlanger
    • Texas
      • Dallas, Texas, United States, 75219
        • Scottish Rite Hospital for Children
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • Shriners Hospitals for Children
      • Plano, Texas, United States, 75024
        • Texas Children's
      • San Antonio, Texas, United States, 78207
        • The Children's Hospital of San Antonio
    • Utah
      • Murray, Utah, United States, 84124
        • Utah Neuro Rehabilitation
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with lower limb spasticity

Description

Inclusion Criteria:

  • Female or male subjects aged 2 to 17 years inclusive
  • Decision to prescribe abobotulinumtoxinA, to be made prior to and independently from the decision to enroll in the study
  • Primary diagnosis of paediatric lower limb (PLL) spasticity and either: Previously untreated with BoNT (naïve to BoNT), or previously treated with a BoNT (i.e. non naïve to BoNT), and for those who were previously treated with BoNT-A, they should have responded to BoNT-A treatment according to the investigator's criteria
  • For non naïve BoNT subjects, a minimum interval of 12 weeks since the last BoNT injection and in the presence of spasticity

Exclusion Criteria:

  • Known resistance to any BoNT or experienced serious safety issues with previous use of BoNT
  • Concomitant treatment with other BoNT
  • Known hypersensitivity to abobotulinumtoxinA or related compounds, or any component in the study drug formulation
  • Subjects with any clinical (or subclinical) evidence of marked defective neuromuscular transmission (e.g. Lambert Eaton syndrome or myasthenia gravis) or persistent clinically significant neuromuscular disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumulated GAS T score
Time Frame: From day 1 up to 30 months
Defined as the mean of the individual GAS T scores across all cycles will be used to measure progress towards individual therapy goals. If all goals are achieved as expected, the GAS T score is 50.0.
From day 1 up to 30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AbobotulinumtoxinA dose
Time Frame: Day 1, then every 3.5 months (approximately) up to 30 months
During each injection cycle and overall
Day 1, then every 3.5 months (approximately) up to 30 months
Time intervals between injections
Time Frame: Day 1, then every 3.5 months (approximately) up to 30 months
During each injection cycle and overall
Day 1, then every 3.5 months (approximately) up to 30 months
Number of injection points
Time Frame: Day 1, then every 3.5 months (approximately) up to 30 months
During each injection cycle and overall
Day 1, then every 3.5 months (approximately) up to 30 months
Muscle(s) injected
Time Frame: Day 1, then every 3.5 months (approximately) up to 30 months
During each injection cycle and overall
Day 1, then every 3.5 months (approximately) up to 30 months
Sedation used
Time Frame: Day 1, then every 3.5 months (approximately) up to 30 months
During each injection cycle and overall
Day 1, then every 3.5 months (approximately) up to 30 months
Type of injection guidance utilised
Time Frame: Day 1, then every 3.5 months (approximately) up to 30 months
During each injection cycle and overall
Day 1, then every 3.5 months (approximately) up to 30 months
Concomitant drug therapies
Time Frame: From day 1 up to 30 months
Listed and tabulated by frequency
From day 1 up to 30 months
Non-drug therapies
Time Frame: From day 1 up to 30 months
Listed and tabulated by frequency
From day 1 up to 30 months
Modified Ashworth scale (as applicable) in the injected muscle groups (gastrocnemius, soleus and others) at baseline and per the investigators' decision/routine practice during the course of the study.
Time Frame: From day 1 up to 30 months (per investigator's decision/routine practice)
This evaluation will not be mandatory during this study. Response over time will be presented using descriptive statistics.
From day 1 up to 30 months (per investigator's decision/routine practice)
Average GAS T score
Time Frame: Day 1 then every 3.5 months (approximately) up to 30 months
Per injection cycle
Day 1 then every 3.5 months (approximately) up to 30 months
Percentage achievement of primary treatment goal
Time Frame: Day 1 then every 3.5 months (approximately) up to 30 months
During each injection cycle and overall
Day 1 then every 3.5 months (approximately) up to 30 months
Percentage achievement of primary treatment goal(s) per goal area(s) after repeated abobotulinumtoxinA injections
Time Frame: Day 1 then every 3.5 months (approximately) up to 30 months
Per injection cycle
Day 1 then every 3.5 months (approximately) up to 30 months
Incidence of adverse events and special situations collected
Time Frame: From day 1 up to 30 months
Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
From day 1 up to 30 months
Direct and indirect health care costs
Time Frame: From day 1 up to 30 months
Derived from the collected data, including concomitant treatments.
From day 1 up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-US-52120-330

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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