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

October 6, 2005
June 18, 2012
February 2003
Not Provided
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 ]
Reduction of spasticity assessed by changes of the Modified Ashworth Spasticity Score from baseline of elbow and wrist flexors in supine anatomical position at week 4.
Complete list of historical versions of study NCT00234546 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Improvement of neurologic outcome (mobility and function) at weeks 4, 8, 12 & 24 (evaluated by Modified Ashworth Scale, Barthel Index, Modified Rankin scale, Functional scale [Motor Assessment Scale])
  • Voluntary and passive joint range of motion goniometer assessment at weeks 4, 8, 12 & 24
  • Pain Assessment using visual analogue scale for pain at weeks 4, 8, 12 & 24
Not Provided
Not Provided
 
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity
A 24-week Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study of Dysport® Injection for the Treatment of Upper Limb Spasticity in Early Stroke.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Muscle Spasticity
  • Cerebrovascular Accident
  • Drug: Botulinum toxin type A (Dysport®)
    1 injection, 500 U at day 0. The study will last for 6 months in each patient.
  • Other: Placebo
    1 injection at day 0. The study will last for 6 months in each patient.
  • Experimental: 1
    Dysport
    Intervention: Drug: Botulinum toxin type A (Dysport®)
  • Placebo Comparator: 2
    Placebo
    Intervention: Other: Placebo
Rosales RL, Kong KH, Goh KJ, Kumthornthip W, Mok VC, Delgado-De Los Santos MM, Chua KS, Abdullah SJ, Zakine B, Maisonobe P, Magis A, Wong KS. Botulinum Toxin Injection for Hypertonicity of the Upper Extremity Within 12 Weeks After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2012 Feb 27. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
October 2007
Not Provided

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong,   Thailand,   Singapore,   Malaysia,   Philippines
 
NCT00234546
A-38-52120-713
Not Provided
Not Provided
Ipsen
Not Provided
Study Director: Axel Magis, MD Ipsen
Ipsen
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP