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

NCT04396704 | Completed

• 1 other identifier: F-GB-52120-268
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Spasticity Related to Any Cause Except Cerebral Palsy

Outcome Measures

Primary Outcomes (6)

• Average Goal Attainment Scale (GAS T) score 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".

  6 weeks

• Average Goal Attainment Scale (GAS T) score 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".

  12 weeks

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

  12 weeks

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

  6 weeks

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

  12 weeks

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

  6 weeks

Secondary Outcomes (10)

• Average total dose

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

• Average dose per limb and per type of muscle injected

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

• Distribution of vials used

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

• Distribution of localisation methods

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

• Distribution of limb and type of muscles injected

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

Study Arms (2)

Botox

all eligible subjects, in a reverse consecutive order, initiated on onaBoNT-A from 01 March 2015 to 29 May 2017.

Dysport

all subjects meeting inclusion/exclusion criteria and initiated on aboBoNT-A from 30 May 2017 to 30 March 2019.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult subjects with Upper Limb Spasticity and/or Lower Limb Spasticity complying with all inclusion and exclusion criteria during the study enrolment period will be included in this study. This study is retrospective and non-interventional, and as such, subjects will have been treated in accordance with usual medical practice during the study period. No additional assessments or tests will be required.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

North Staffordshire Rehabilitation Centre. Midlands Partnership NHS Foundation Trust.

Stafford, ST6 7AG, United Kingdom

Location

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 20, 2020
• Study Start: January 11, 2021
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Locations

GB (1)