Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Phase 4

Completed

• Conditions: Muscle Spasticity; Cerebrovascular Accident
• Interventions: Biological: Botulinum toxin type A; Drug: Placebo

• Registration Number: NCT00234546
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-07
• Study Completion: 2007-10
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Botulinum toxin type A	Dysport
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position	week 4

Secondary Outcome Measures

Name	Time	Method
Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale)	weeks 4, 8, 12 & 24
Voluntary and passive joint range of motion goniometer assessment	weeks 4, 8, 12 & 24
Pain Assessment using visual analogue scale for pain	weeks 4, 8, 12 & 24

Trial Locations

Locations (5)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

University Hospital of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia

University of Santo Tomas; 🇵🇭 Manila, Philippines

TTSH Rehabilitation Centre; 🇸🇬 Singapore, Singapore