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Completed

NCT Number: NCT00234546

Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

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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Key information

Conditions

Muscle Spasticity Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Muscle Hypertonia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prince of Wales Hospital, Shatin, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

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

Other names: AbobotulinumtoxinA (Dysport®)

Placebo

Drug

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

Primary outcomes

  1. Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position

    Time frame: week 4

Secondary outcomes

  1. Improvement of neurologic outcome (mobility and function), evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale (Motor Assessment Scale)

    Time frame: weeks 4, 8, 12 & 24

  2. Voluntary and passive joint range of motion goniometer assessment

    Time frame: weeks 4, 8, 12 & 24

  3. Pain Assessment using visual analogue scale for pain

    Time frame: weeks 4, 8, 12 & 24

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A 24-week Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study of Dysport® Injection for the Treatment of Upper Limb Spasticity in Early Stroke.

Important dates

Study start
2003
Study completion
2007
First posted
Oct 7, 2005
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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