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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01249404
Registration number
NCT01249404
Ethics application status
Date submitted
25/11/2010
Date registered
29/11/2010
Date last updated
28/09/2022
Titles & IDs
Public title
Dysport® Adult Lower Limb Spasticity Study
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Scientific title
A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
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Secondary ID [1]
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2009-015868-34
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Secondary ID [2]
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Y-55-52120-140
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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:
Leg 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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Botulinum toxin type A
Treatment: Drugs - Placebo
Experimental: Dysport® 1000 U, IM - 1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
Experimental: Dysport® 1500 U, IM - 1500 U, I.M., on day 1 (single treatment cycle)
Placebo Comparator: Placebo - I.M., on day 1 (single treatment cycle)
Other interventions: Botulinum toxin type A
I.M. injection on day 1 (single treatment cycle)
Treatment: Drugs: Placebo
I.M. injection on day 1 (single treatment cycle)
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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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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Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
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Assessment method [1]
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Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion (ROM)), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.
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Timepoint [1]
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Baseline and Week 4
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Secondary outcome [1]
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Physician's Global Assesment (PGA) of Treatment Response at Week 4
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Assessment method [1]
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An assessment of overall treatment response was conducted at Weeks 4 and 12, and discretionary visits at Weeks 16, 20 and 24 and at end of study by an investigator who had not assessed the MAS. The investigator rated the response to treatment in the subject's lower limb after injection of Dysport® relative to the status at the baseline. Answers were made on a 9 point rating scale: -4=markedly worse, -3=much worse, -2=worse, -1=slightly worse, 0=no change, +1=slightly improved, +2=improved, +3=much improved, +4=markedly improved. The mean PGA score at Week 4 is reported.
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Timepoint [1]
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At Week 4
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Secondary outcome [2]
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Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed
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Assessment method [2]
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Comfortable walking speed was assessed as a measure of functional ability and gait over 10 metres. Evaluations were made barefoot, without walking aids, at baseline and Weeks 1, 4 and 12 and discretionary visits at Weeks 16, 20 and 24 and at end of study. The least squares mean change from baseline at Week 4 is reported.
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Timepoint [2]
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Baseline and Week 4
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Eligibility
Key inclusion criteria
- Subjects aged 18 to 80 years of age
- Post stroke or brain injury
- Intensity of muscle tone greater than or equal to 2, as measured on the Modified
Ashworth Scale
- Ambulatory patients
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Minimum age
18
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Maximum age
80
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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
- Fixed contractures
- Physiotherapy initiated less than 4 weeks before entry
- Previous surgery or previous treatment with phenol and/or alcohol in lower limb
- Neurological/neuromuscular disorders which may interfere with protocol evaluations
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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 assessing the outcomes
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 3
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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
1/03/2011
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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
1/05/2014
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Sample size
Target
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Accrual to date
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Final
388
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Epworth HealthCare - Richmond
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Caulfield Hospital - Caulfield
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Saint Vincent's Hospital - Darlinghurst
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Saint Vincent's Hospital - Fitzroy
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St George Hospital - Kogarah
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [7]
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Epworth Healthcare - Richmond
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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3121 - Richmond
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Recruitment postcode(s) [2]
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3162 - Caulfield
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Recruitment postcode(s) [3]
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- Darlinghurst
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- Fitzroy
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- Kogarah
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Recruitment postcode(s) [6]
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- Parkville
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Recruitment postcode(s) [7]
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- Richmond
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Recruitment postcode(s) [8]
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- Westmead
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Recruitment outside Australia
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United States of America
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Arizona
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Bratislava
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo
in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or
traumatic brain injury.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01249404
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Contacts
Principal investigator
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Ipsen Study Director
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Ipsen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01249404
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