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Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234546
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : July 26, 2019
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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.

Condition or disease Intervention/treatment Phase
Muscle Spasticity Cerebrovascular Accident Biological: Botulinum toxin type A Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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.
Study Start Date : February 2003
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: 1
Biological: Botulinum toxin type A
1 injection, 500 U at day 0. The study will last for 6 months in each patient.
Other Name: AbobotulinumtoxinA (Dysport®)

Placebo Comparator: 2
Drug: Placebo
1 injection at day 0. The study will last for 6 months in each patient.

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234546

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Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
University Hospital of Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
University of Santo Tomas
Manila, Philippines, 3001 MAB
TTSH Rehabilitation Centre
Singapore, Singapore, 569766
Siriraj Hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
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Study Director: Ipsen Medical Director Ipsen

Publications of Results:
Layout table for additonal information Identifier: NCT00234546     History of Changes
Other Study ID Numbers: A-38-52120-713
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents