Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00234546
First received: October 6, 2005
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Muscle Spasticity
Cerebrovascular Accident
Drug: Botulinum toxin type A (Dysport®)
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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:
  • 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 ]
  • Voluntary and passive joint range of motion goniometer assessment [ Time Frame: weeks 4, 8, 12 & 24 ]
  • Pain Assessment using visual analogue scale for pain [ Time Frame: weeks 4, 8, 12 & 24 ]

Enrollment: 162
Study Start Date: February 2003
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: 1
Dysport
Drug: Botulinum toxin type A (Dysport®)
1 injection, 500 U at day 0. The study will last for 6 months in each patient.
Placebo Comparator: 2
Placebo
Other: Placebo
1 injection at day 0. The study will last for 6 months in each patient.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00234546

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

Publications:
ClinicalTrials.gov Identifier: NCT00234546     History of Changes
Other Study ID Numbers: A-38-52120-713
Study First Received: October 6, 2005
Last Updated: June 18, 2012
Health Authority: Hong Kong: Hong Kong Hospital Authority
Malaysia: National Pharmaceutical Control Bureau
Philippines: Department of Health
Singapore: Health Sciences Authority
Thailand: The Ethical Committee on Research Involving Human Subjects

Additional relevant MeSH terms:
Muscle Spasticity
Cerebral Infarction
Stroke
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014