Keywords: spasticy , stroke , TBI
IRB Number: 00052963
Specialty: Physical Medicine and Rehabilitation, Physical Medicine and Rehabilitation, Physical Medicine and Rehabilitation
Sub Specialties: Spasticity Management, Stroke , Traumatic Brain Injury
Dysport has been investigated in a number of studies of upper and lower limb spasticity of various etiologies in adults and in children. In these studies improvements in spasticity and muscle tone were observed in targeted muscles. Dysport is licensed in over 75 countries for various indications including the treatment of adult upper limb spasticity. The maximum dose for this
indication is 1000 U.
The upper limb is often adversely affected by stroke or traumatic brain injury, resulting in spasticity which can affect subject’s activities of daily life. However,
few studies have assessed at the same time the effects of BTX on muscle tone,
passive and active function, and spasticity in this subject population.
The present phase III, multicentre, prospective, double blind, randomised, placebo
controlled, single treatment cycle study has been designed to assess the efficacy of
Dysport for the treatment of upper limb spasticity in adult subjects with hemiparesis
due to stroke or traumatic brain injury. Effects of muscle tone on the primary
targeted muscle group (using the Modified Ashworth Scale (MAS)) will be assessed
as primary criterion.
Both the efficacy and safety profile of Dysport administered at 500 U and 1000 U
will be compared to placebo. Long term safety and efficacy will be assessed in an
open label extension study for all eligible subjects.
Principle Investigator: Steven Edgley
Principle Department: Physical Medicine & Rehab