Status:
COMPLETED
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity
Lead Sponsor:
Ipsen
Conditions:
Muscle Spasticity
Cerebrovascular Accident
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT00234546
Start Date
February 1 2003
End Date
October 1 2007
Last Update
July 26 2019
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Prince of Wales Hospital
Shatin, Hong Kong
2
University Hospital of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
3
University of Santo Tomas
Manila, Philippines, 3001 MAB
4
TTSH Rehabilitation Centre
Singapore, Singapore, 569766