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

Ipsen

Status: Completed

Conditions: Spasticity Related to Any Cause Except Cerebral Palsy

Study type: Observational

Funder types: Industry

Identifiers

NCT04396704

F-GB-52120-268

Details and patient eligibility

About

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).

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

114 participants in 2 patient groups

Botox

Description:

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

Dysport

Description:

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