Skip to main content
OpenTrials
Completed

NCT Number: NCT03017729

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lower Limb Spasticity

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Medical Center, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

This is an observational study designed to reflect real world clinical practice in the use of abobotulinumtoxinA. AbobotulinumtoxinA injected doses, frequency of injections, number of injection sites and volume injected per site are in accordance with the current USPI and physician's clinical practice.

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

  1. 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.

Secondary outcomes

  1. AbobotulinumtoxinA dose

    Time frame: Day 1, then every 3.5 months (approximately) up to 30 months

    During each injection cycle and overall

  2. Time intervals between injections

    Time frame: Day 1, then every 3.5 months (approximately) up to 30 months

    During each injection cycle and overall

  3. Number of injection points

    Time frame: Day 1, then every 3.5 months (approximately) up to 30 months

    During each injection cycle and overall

  4. Muscle(s) injected

    Time frame: Day 1, then every 3.5 months (approximately) up to 30 months

    During each injection cycle and overall

  5. Sedation used

    Time frame: Day 1, then every 3.5 months (approximately) up to 30 months

    During each injection cycle and overall

  6. 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

  7. Concomitant drug therapies

    Time frame: From day 1 up to 30 months

    Listed and tabulated by frequency

  8. Non-drug therapies

    Time frame: From day 1 up to 30 months

    Listed and tabulated by frequency

  9. 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.

  10. Average GAS T score

    Time frame: Day 1 then every 3.5 months (approximately) up to 30 months

    Per injection cycle

  11. 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

  12. 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

  13. 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).

  14. Direct and indirect health care costs

    Time frame: From day 1 up to 30 months

    Derived from the collected data, including concomitant treatments.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 11, 2017
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.