A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety of Dysport intramuscular injections used for the treatment of lower limb sp...

Mise à jour : Il y a 5 ans
Référence : EUCTR2009-015868-34

A phase III, multicentre, prospective, double blind, randomised, placebo controlled study, assessing the efficacy and safety of Dysport intramuscular injections used for the treatment of lower limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury

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Extrait

The primary study objective is to assess the efficacy of Dysport compared to placebo at Week 4 on the change from baseline in the gastrocnemius-soleus complex (GSC) muscle tone (knee extended) in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.


Critère d'inclusion

  • Leg Spasticity