DYSPORT - retrospective study in patients with limb spacticity

• Research type

  Research Study

• Full 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

• IRAS ID

  270474

• Contact name

  Clive Bezzina

• Contact email

  Clive.bezzina@mpft.nhs.uk

• Sponsor organisation

  Ipsen Limited

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  0 years, 1 months, 20 days

• Research summary

  This is a single centre, non-interventional, retrospective study to assess treatment outcomes in real life practice between abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) in toxin-naïve adult patients with limb spasticity. This study will be conducted in 1 NHS centre in the United Kingdom (UK).

  The study is based on retrospective collection of data from patients’ medical records. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required.

  The population for this study is adult patients diagnosed with limb spasticity who received treatment with abobotulinumtoxinA or onabotulinumtoxinA as part of their standard clinical care. It is expected to recruit 100-200 patients in total.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  20/WM/0203

• Date of REC Opinion

  27 Jul 2020

• REC opinion

  Favourable Opinion