Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

A 24-week Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study of Dysport® Injection for the Treatment of Upper Limb Spasticity in Early Stroke.

The aim of this clinical study is to investigate the efficacy and safety of Dysport® in patients with early onset of upper limb spasticity within 2-12 weeks after stroke.

Inclusion Criteria:

• First-ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on CT/MRI is not counted as previous stroke)
• CT/MRI scan required to classify ischaemic / haemorrhagic stroke
• Patient recruited 2-12 weeks after stroke
• Modified Ashworth Spasticity Score 1+ or above in either elbow or wrist joint

Exclusion Criteria:

• The patient has bleeding disturbances or having used coumarin derivatives
• The patient is currently receiving drugs affecting neuromuscular transmission
• Co-existing severe systemic illness which may adversely affect the functional outcome
• Pre-existing neuromuscular junction disease or any neurogenic disorders which can interfere with spasticity