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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234546

Enrollment

162

Registered

2005-10-07

Start date

2003-02-28

Completion date

2007-10-31

Last updated

2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident, Muscle Spasticity

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.

Interventions

BIOLOGICALBotulinum toxin type A

1 injection, 500 U at day 0. The study will last for 6 months in each patient.

DRUGPlacebo

1 injection at day 0. The study will last for 6 months in each patient.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Hong Kong, Malaysia, Philippines, Singapore, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026