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Lower Limb SpasticityNCT03017729

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

An observational study of Lower Limb Spasticity, run by Ipsen at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Lower Limb Spasticity
What is being tested?
Botulinum toxin type A
Type of treatment
Injection or infusion
How many people
242 participants
Where
27 sitesUnited States
Study dates
10 Feb 2017to 30 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Pediatric patients with lower limb spasticity

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308

  • Good Shepherd Rehabilitation Network

    Allentown, Pennsylvania, 18103

  • Clinical Integrative Research Central Atlanta

    Atlanta, Georgia, 30328

  • Mt. Washington Pediatric Hospital

    Baltimore, Maryland, 21209

  • The Children's Center

    Bethany, Oklahoma, 73008

  • Children's Hospital at Erlanger

    Chattanooga, Tennessee, 37403

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Missouri

    Columbia, Missouri, 65212

  • Scottish Rite Hospital for Children

    Dallas, Texas, 75219

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

  • Shriners Hospitals for Children

    Greenville, South Carolina, 29605

  • Shriners Hospitals for Children

    Houston, Texas, 77030

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Utah Neuro Rehabilitation

    Murray, Utah, 84124

  • Laszlo J. Mate, M.D.

    North Palm Beach, Florida, 33408

  • Shriners Hospitals for Children

    Philadelphia, Pennsylvania, 19140

  • Texas Children's

    Plano, Texas, 75024

  • Shriners Hospitals for Children

    Portland, Oregon, 97239

  • Valley Health System

    Ridgewood, New Jersey, 07450

  • William Beaumont Hospital Pediatric Research

    Royal Oak, Michigan, 48073

  • Gillette Children's Specialty Healthcare

    Saint Paul, Minnesota, 55101

  • The Children's Hospital of San Antonio

    San Antonio, Texas, 78207

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: 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).

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type ABiological

    Also called AbobotulinumtoxinA (Dysport®)

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulated GAS T score

    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.

    Measured: From day 1 up to 30 months

Secondary outcomes (14)

  1. AbobotulinumtoxinA dose

    During each injection cycle and overall

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

  2. Time intervals between injections

    During each injection cycle and overall

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

  3. Number of injection points

    During each injection cycle and overall

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

  4. Muscle(s) injected

    During each injection cycle and overall

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

  5. Sedation used

    During each injection cycle and overall

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

  6. Type of injection guidance utilised

    During each injection cycle and overall

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

  7. Concomitant drug therapies

    Listed and tabulated by frequency

    Measured: From day 1 up to 30 months

  8. Non-drug therapies

    Listed and tabulated by frequency

    Measured: From day 1 up to 30 months

  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.

    This evaluation will not be mandatory during this study. Response over time will be presented using descriptive statistics.

    Measured: From day 1 up to 30 months (per investigator's decision/routine practice)

  10. Average GAS T score

    Per injection cycle

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

  11. Percentage achievement of primary treatment goal

    During each injection cycle and overall

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

  12. Percentage achievement of primary treatment goal(s) per goal area(s) after repeated abobotulinumtoxinA injections

    Per injection cycle

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

  13. Incidence of adverse events and special situations collected

    Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).

    Measured: From day 1 up to 30 months

  14. Direct and indirect health care costs

    Derived from the collected data, including concomitant treatments.

    Measured: From day 1 up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start10 Feb 2017
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017729
Sponsor's protocol ID
A-US-52120-330
Status last verified
Dec 2020
First submitted
30 Dec 2016
Last updated
19 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Limb Spasticity, run by Ipsen at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulated GAS T score (time frame: From day 1 up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.

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