NCT02969356

Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC)

An International, Multicentre, Prospective, Single-Arm Study to Assess the Effect on Voluntary Movements of AbobotulinumtoxinA 1500 U Administered in Both Upper and Lower Limbs in Conjunction With a Guided Self-Rehabilitation Contract in Adult Subjects With Spastic Hemiparesis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to assess whether AbobotulinumtoxinA (Dysport®) injections in upper and lower limbs accompanied with a personal exercise plan called "Guided Self-rehabilitation Contract" (GSC) can improve voluntary movements in subjects with hemiparesis.

Conditions

• Spastic Hemiparesis

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	Dysport® administered in both upper and lower limbs (total dose of 1500 U per injection split between the 2 limbs).
OTHER	GSC	The GSC is a motivational tool. The physiotherapist will teach each subject the stretching postures and exercises to perform on a daily basis throughout the study. These will be tailored to the individual subject's needs and will form the GSC therapy.

Timeline

• Start date: 2016-12-18
• Primary completion: 2018-04-26
• Completion: 2018-07-01
• First posted: 2016-11-21
• Last updated: 2025-02-19
• Results posted: 2019-06-04

Locations

19 sites across 4 countries: United States, Czechia, France, Russia

Regulatory

• FDA-regulated drug study