Phase III, multicentre study assessing the efficacy and safety of Dysport compared to a Placebo for the treatment of upper limb spasticity in adult patients with hemiparesis

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-019069-28

Femme et Homme

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Extrait

The primary study objective is to assess the efficacy of Dysport compared to placebo in reducing upper limb muscle tone in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury. The primary study objective will be assessed by comparing between treatment groups at Week 4 the change from baseline in muscle tone (using the Modified Ashworth Scale (MAS)) in the primary targeted muscle group.


Critère d'inclusion

  • Arm spasticity