Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

Ipsen

Status and phase: Completed; Phase 4

Conditions: Cerebrovascular Accident; Muscle Spasticity

Treatments: Drug: Placebo; Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00234546

A-38-52120-713

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Dysport

Treatment:

Biological: Botulinum toxin type A

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo