Asian Botulinum Clinical Trial Designed for Early Stroke Spasticity

July 25, 2019 updated by: Ipsen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Hospital of Malaya Medical Centre
  • Philippines
      • Manila, Philippines, 3001 MAB
        • University of Santo Tomas
  • Singapore
      • Singapore, Singapore, 569766
        • TTSH Rehabilitation Centre
  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
1 injection at day 0. The study will last for 6 months in each patient.
Experimental: 1
Dysport
Biological: Botulinum toxin type A
1 injection, 500 U at day 0. The study will last for 6 months in each patient.
Other Names:
  • AbobotulinumtoxinA (Dysport®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
week 4

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 7, 2005

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 25, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-38-52120-713

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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