Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (RESULT)

Ipsen

Status: Completed

Conditions: Spasticity

Study type: Observational

Funder types: Industry

Identifiers

NCT04340336

A-IT-52120-264

Details and patient eligibility

About

The aim of the study is to describe the long term use of Botulinum Neurotoxin Type A (BoNT-A) in adult subjects affected with upper and/or lower limb spasticity who received treatment with BoNT-A for a minimum of three injections cycles at three Italian centers.

The study has a retrospective design and data relating to subjects' injections cycles occurred in the past are collected. Period of observation defined in the protocol is from 2008 to 2018, but it could change for each subject according to the number of injections cycles performed. Time frame for data collection is 12 months from study start.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult aged ≥18 years old at the time of the first BoNT-A injection
• Diagnosed with spasticity with any cause (excluded CP)
• Treated with a minimum of three BoNT-A treatment cycles for upper limb spasticity (ULS) and/or lower limb spasticity (LLS)
• With follow up data available in the subject's medical record
• Provision of written informed consent form, to the extent required according to applicable national local regulations for a retrospective, non-interventional study

Exclusion criteria

• Treatments and assessments were performed at more than one centre