A Phase III, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT Used In The Treatment Of Upper Limb Spasticity In Children
Phase of Trial: Phase III
Latest Information Update: 13 Oct 2019
Price : $35 *
At a glance
- Drugs Botulinum-Toxin-A (Primary)
- Indications Muscle spasticity
- Focus Registrational; Therapeutic Use
- Acronyms PUL
- Sponsors Ipsen
- 26 Sep 2019 Primary endpoint has been met. (Mean change from baseline in the Primary Targeted Muscle Group on Modified Ashworth Scale (MAS)), according to an Ipsen media release.
- 26 Sep 2019 Results presented in an Ipsen media release.
- 26 Sep 2019 According to an Ipsen media release, based on the data from this study, the United States Food and Drug Administration (FDA) has expanded the use of Dysport (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP).