Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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