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Completed

NCT Number: NCT04396704

A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.

The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or lower limb spasticity at a single National Health Service (NHS) centre in the United Kingdom (UK).

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Key information

Conditions

Spasticity Related to Any Cause Except Cerebral Palsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.

Stafford, ST6 7AG, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient diagnosed with spasticity related to any cause except cerebral palsy.
  • Patient initiated on treatment with either onaBoNT-A or aboBoNT-A during the study enrolment periods.
  • Patient is an adult aged ≥18 years old at the time of the first BoNT-A injection for spasticity
  • Patient has not received treatment with any type of BoNT-A 6 months prior to initiation of onaBoNT-A or aboBoNT-A. For patients with multiple courses of BoNT-A, separated by a gap of 6 months, only the first course will be evaluated in this study.
  • Patient is being treated at Haywood Hospital at index date and during follow-up for up to 24 weeks post-index date, with medical records available for review.

Exclusion criteria

  • Patient is participating in an interventional clinical trial of an investigational medicinal product for the treatment of spasticity at index date and/or during follow-up.

Treatment and study plan

Primary outcomes

  1. Average Goal Attainment Scale (GAS T) score 6 weeks

    Time frame: 6 weeks

    GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".

  2. Average Goal Attainment Scale (GAS T) score 12 weeks

    Time frame: 12 weeks

    GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".

  3. Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal

    Time frame: 12 weeks

  4. Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal

    Time frame: 6 weeks

  5. Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal

    Time frame: 12 weeks

  6. Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal

    Time frame: 6 weeks

Secondary outcomes

  1. Average total dose

    Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)

  2. Average dose per limb and per type of muscle injected

    Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)

  3. Distribution of vials used

    Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)

    If Dysport® 300U / 500U, if Botox® 50U / 100U / 200U

  4. Distribution of localisation methods

    Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)

    Ultrasound, electrostimulation, palpation, electromyography

  5. Distribution of limb and type of muscles injected

    Time frame: Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection)

    Upper limb: shoulder girdle, shoulder, arm, forearm, hand; lower limb: hip, thigh, leg and foot

  6. Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A

    Time frame: Week 6 and week 12 (re-injection)

  7. Quality of Life (QoL)

    Time frame: From baseline up to 12 weeks

    The EQ-5D-VAS is used to evaluate patients' quality of life. EQ-5D-VAS is one component of the EQ-5D-5L, a generic, preference-based measure of health-related quality of life. The questions are answered based on how the subject is feeling "today".

  8. Average number of unscheduled visits

    Time frame: From baseline up to end of the study (up to 24 weeks)

  9. Proportion of patients with ≥1 unscheduled visit

    Time frame: From baseline up to end of the study (up to 24 weeks)

  10. Proportion of patients with at least "the same", or at least "better" satisfaction with their treatment as measured using a Likert scale

    Time frame: From baseline up to 12 weeks

    A Likert scale is used to record patient's satisfaction with his/her progress, and the patient's "best response" (since index date) and "response now" (at the time of the review) on a five-category scale: From "Much worse" to "Much better"

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Single Centre, Non-interventional, Retrospective Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2020
Registry last updated
May 21, 2021

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.

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