Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Muscle Spasticity Cerebrovascular Accident

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Dysport

Group Type EXPERIMENTAL

Botulinum toxin type A

Intervention Type BIOLOGICAL

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

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Botulinum toxin type A

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

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type DRUG

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No