NCT02321436

Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression

Asian Multicentre, Double Blind, Randomised, Placebo Controlled Pilot Study, to Assess the Impact of Dysport® Intramuscular Injections When Administered Within the First 12 Weeks After Stroke on the Time to Spasticity Progression in Adult Subjects With Upper Limb (UL) Spasticity.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic spasticity.

Conditions

• Stroke
• Upper Limb Spasticity

Interventions

Type	Name	Description
BIOLOGICAL	Botulinum toxin type A	Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.
DRUG	Placebo	Placebo administered intramuscularly in the targeted upper limb.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-12-22
• Last updated: 2022-09-28
• Results posted: 2017-06-26

Locations

4 sites across 4 countries: Malaysia, Philippines, Singapore, Thailand