Keywords: Spasticity , Stroke , TBI
IRB Number: 00048709
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 lower limb spasticity. The maximum dose for this indication is 1500 U.
A prospective, single treatment cycle, multinational, multicentre, placebo controlled, dose-ranging study was conducted in adult subjects with spastic equinovarus deformity of the foot using three doses of Dysport (500 U, 1000 U, 1500 U) and injecting the gastrocnemius-soleus complex (GSC). The greatest benefits on muscle tone (MAS) were observed in subjects receiving the 1500 U Dysport dose. Improvement in pain and dependence on walking aids was also reported in the 1500 U Dysport treatment groups as compared to placebo. All three doses of Dysport were well tolerated, with a similar number of subjects reporting adverse events in all groups including placebo.
The present Phase III, double blind, single treatment cycle, multicentre, prospective, randomized, placebo controlled study has been designed to assess the efficacy of Dysport for the treatment of lower limb spasticity in adult subjects with hemiparesis due to stroke or traumatic brain injury. Effects on the GSC muscle tone will be assessed as primary criterion, the Physician Global Assessment of treatment response and the comfortable barefoot walking speed will be considered as secondary endpoints. Both the efficacy and safety profile of Dysport administered at 1000 U and 1500 U will be compared to placebo. Long-term safety and efficacy will be assessed in an open label extension study for all eligible subjects (IRB#50826).
Principal Investigator: Steven Edgley
Department: Physical Medicine & Rehab