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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00216411
Registration number
NCT00216411
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
29/07/2019
Titles & IDs
Public title
Effects on Quality of Life Following Dysport Treatment in Post-stroke Spasticity of the Arm
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Scientific 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
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Secondary ID [1]
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A-9B-52120-097
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cerebrovascular Accident
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Muscle Spasticity
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Dysport -
Placebo comparator: Placebo -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in quality of life measured using the Assessment of Quality of Life questionnaire (12 question version).
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Change in muscle spasticity assessed on Modified Ashworth Scale (MAS)
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Change in the Modified Motor Assessment Scale
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Change in patient disability and carer burden rating scale total score
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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Achievement of the patient identified functional outcome measures (Goal Attainment Scaling)
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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Change in the degree of pain
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Change in depression rating scale total score
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Global assessment of benefit
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Assessment method [7]
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Timepoint [7]
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
20/07/2006
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Sample size
Target
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Accrual to date
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Final
96
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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St Josephs Hospital - Auburn
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
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Box Hill Hospital - Box Hill
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Recruitment hospital [5]
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Caulfield General Medical Centre - Caulfield
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Recruitment hospital [6]
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Austin Health - Heidelberg
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Recruitment postcode(s) [1]
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2144 - Auburn
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3162 - Caulfield
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ipsen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00216411
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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Ipsen Medical Director
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Address
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Ipsen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00216411
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