Back to resultsEffects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
Primary Purpose
Cerebrovascular Accident, Muscle Spasticity
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Botulinum toxin type A
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident
Eligibility Criteria
Inclusion Criteria: The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously. The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale. The patient has the cognitive and communication ability to participate in the study. Exclusion Criteria: Patients who have received botulinum toxin treatment within the past 120 days. Contraindication to botulinum toxin treatment. Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry. Patients who have previously been treated with phenol for their upper limb spasticity.
Sites / Locations
- St Josephs Hospital
- Royal Prince Alfred Hospital
- Prince of Wales Hospital
- Box Hill Hospital
- Caulfield General Medical Centre
- Austin Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dysport
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Secondary Outcome Measures
Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
Change in the Modified Motor Assessment Scale
Change in patient disability and carer burden rating scale total score
Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
Change in the degree of pain
Change in depression rating scale total score
Global assessment of benefit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00216411
Brief Title
Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
Official Title
A Prospective Phase IV, Multicentre, Placebo-controlled Study to Demonstrate Changes in the Quality of Life Following DYSPORT Intramuscular Injection in the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
July 20, 2006 (Actual)
Study Completion Date
July 20, 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
Brief Summary
The main purpose of this study is to assess the effect on Quality of Life of two cycles of Dysport treatment on post-stroke spasticity of the upper limb. The effect of treatment on spasticity and function will also be measured.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Muscle Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dysport
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
Secondary Outcome Measure Information:
Title
Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
Title
Change in the Modified Motor Assessment Scale
Title
Change in patient disability and carer burden rating scale total score
Title
Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
Title
Change in the degree of pain
Title
Change in depression rating scale total score
Title
Global assessment of benefit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient has suffered a stroke, as defined by the World Health Organisation (WHO) criteria, at least 6 months previously.
The patient has a hemiparetic arm and meets minimum score requirements on the Modified Ashworth Scale.
The patient has the cognitive and communication ability to participate in the study.
Exclusion Criteria:
Patients who have received botulinum toxin treatment within the past 120 days.
Contraindication to botulinum toxin treatment.
Patients who are receiving oral anti-spasticity medication and who have had a change in dosage of this medication in the month prior to study entry.
Patients who have previously been treated with phenol for their upper limb 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
St Josephs Hospital
City
Auburn
State/Province
New South Wales
ZIP/Postal Code
2144
Country
Australia
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Caulfield General Medical Centre
City
Caulfield
State/Province
Victoria
ZIP/Postal Code
3162
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
20111849
Citation
Turner-Stokes L, Baguley IJ, De Graaff S, Katrak P, Davies L, McCrory P, Hughes A. Goal attainment scaling in the evaluation of treatment of upper limb spasticity with botulinum toxin: a secondary analysis from a double-blind placebo-controlled randomized clinical trial. J Rehabil Med. 2010 Jan;42(1):81-9. doi: 10.2340/16501977-0474.
Results Reference
derived
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Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
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