Back to resultsAsian Botulinum Clinical Trial Designed for Early Stroke Spasticity
Primary Purpose
Muscle Spasticity, Cerebrovascular Accident
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Spasticity
Eligibility 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
Sites / Locations
- Prince of Wales Hospital
- University Hospital of Malaya Medical Centre
- University of Santo Tomas
- TTSH Rehabilitation Centre
- Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Dysport
Placebo
Outcomes
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
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)
Voluntary and passive joint range of motion goniometer assessment
Pain Assessment using visual analogue scale for pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00234546
Brief Title
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity
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 Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Spasticity, Cerebrovascular Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Dysport
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Description
1 injection, 500 U at day 0. The study will last for 6 months in each patient.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 injection at day 0. The study will last for 6 months in each patient.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Voluntary and passive joint range of motion goniometer assessment
Time Frame
weeks 4, 8, 12 & 24
Title
Pain Assessment using visual analogue scale for pain
Time Frame
weeks 4, 8, 12 & 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
University Hospital of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
University of Santo Tomas
City
Manila
ZIP/Postal Code
3001 MAB
Country
Philippines
Facility Name
TTSH Rehabilitation Centre
City
Singapore
ZIP/Postal Code
569766
Country
Singapore
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
22371239
Citation
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 Sep;26(7):812-21. doi: 10.1177/1545968311430824. Epub 2012 Feb 27.
Results Reference
result
Learn more about this trial
Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity
We'll reach out to this number within 24 hrs