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

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ClinicalTrials.gov Identifier: NCT03017729
Recruitment Status : Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : December 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
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).

Condition or disease Intervention/treatment
Lower Limb Spasticity Drug: AbobotulinumtoxinA

Study Type : Observational
Actual Enrollment : 242 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Prospective, Observational, Multicentre Study Evaluating the Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity.
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox


Intervention Details:
  • Drug: AbobotulinumtoxinA
    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 Name: Dysport®


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients with lower limb spasticity
Criteria

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

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): NCT03017729


  Show 27 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Ipsen Medical Director Ipsen

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03017729     History of Changes
Other Study ID Numbers: A-US-52120-330
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
abobotulinumtoxinA
Botulinum Toxins, Type A
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents