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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06259006
Registration number
NCT06259006
Ethics application status
Date submitted
22/01/2024
Date registered
14/02/2024
Titles & IDs
Public title
TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
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Scientific title
TREAT-SC: A Randomised, Double-Blinded, Placebo-Controlled Trial of Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
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Secondary ID [1]
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StarshipChild
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Universal Trial Number (UTN)
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Trial acronym
TREAT-SC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatic Fever
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Sydenham Chorea
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Infection
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Other infectious diseases
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Neurological
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0
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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
Treatment: Drugs - Dexamethasone Oral
Treatment: Drugs - Placebo
Experimental: Dexamethasone - Participants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days
Placebo comparator: Placebo control - Participants will receive oral placebo tablet three times a day for 3 days
Treatment: Drugs: Dexamethasone Oral
4mg capsules taken orally in three divided doses to a total daily dose of 20mg/m2 (maximum dose 24mg/day) for three days
Treatment: Drugs: Placebo
Matching capsules taken orally three times daily for three days
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Intervention code [1]
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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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Chorea severity at 1 month
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Assessment method [1]
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Chorea severity measured using the Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale. Scores range from 0 to 108. A higher score correlates with a worse outcome.
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Timepoint [1]
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1 month
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Secondary outcome [1]
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Adverse events
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Assessment method [1]
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Frequency of adverse events
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Timepoint [1]
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3 days, 7 days, 1 month
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Secondary outcome [2]
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Chorea severity
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Assessment method [2]
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Chorea severity measured using the Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale. Scores range from 0 to 108. A higher score correlates with a worse outcome.
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Timepoint [2]
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7 days, 3 months, 12 months
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Secondary outcome [3]
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Total hospital length of stay
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Assessment method [3]
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Total hospital length of stay for chorea at three months
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Timepoint [3]
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3 months
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Secondary outcome [4]
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Treatment failure at 14 days
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Assessment method [4]
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Number of participants with treatment failure at 14 days
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Timepoint [4]
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14 days
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Secondary outcome [5]
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Use of adjunctive chorea treatments
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Assessment method [5]
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Number of participants treated with adjunctive chorea treatments
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Timepoint [5]
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1 month
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Secondary outcome [6]
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Chorea relapse and recurrence
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Assessment method [6]
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Number of participants with chorea relapse and recurrence at 3 and 12 months
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Timepoint [6]
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3 and 12 months
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Secondary outcome [7]
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Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale Subscores.
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Assessment method [7]
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Behaviour (0 to 24 points), Activities of Daily Living (0 to 28 points) and Motor Assessment (0-56 points). A higher score correlates with a worse outcome.
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Timepoint [7]
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7 days, 1 month, 3 months, 12 months
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Secondary outcome [8]
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Psychiatric symptoms
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Assessment method [8]
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Strength and Difficulties Questionnaire Total Difficulties Score. The resultant score ranges from 0 to 40. An abnormally high total difficulties score correlates with worse outcome.
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Timepoint [8]
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1 month, 3 months and 12 months
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Eligibility
Key inclusion criteria
1. Sydenham's chorea of any severity diagnosed by a paediatrician or neurologist based on national ARF guidelines
2. Child or adolescents aged 4 years to <18 years of age
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Minimum age
4
Years
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Maximum age
17
Years
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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
1. Administered steroids or intravenous immunoglobulin since onset of the current Sydenham's chorea episode
2. Evidence of concomitant severe, acute infection
3. History of hypersensitivity to dexamethasone or its excipients
4. Pregnancy
5. Confirmed exposure of an unimmunised child to measles, mumps, rubella or chickenpox within the previous four weeks
6. Receipt of a live vaccine within the previous four weeks
7. Medical condition or treatment with medication which in the opinion of the trial investigators would make the child unsuitable for the trial
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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 administering 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
Not yet recruiting
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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
1/05/2024
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Actual
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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
1/05/2028
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
Northern Territorie
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Recruitment hospital [1]
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Royal Darwin Hospital - Darwin
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Recruitment postcode(s) [1]
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0810 - Darwin
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Starship Child Health, Te Toka Tumai Auckland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Health Research Council, New Zealand
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Menzies School of Health Research
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to find out whether an early three-day course of an oral steroid medication (dexamethasone) can improve the physical and mental recovery and wellbeing for children with Sydenham's chorea. Sydenham's chorea is a condition that impacts approximately 12% of children with acute rheumatic fever. It is caused by inflammation in the brain following an abnormal immune response to Group A streptococcus bacterial infection. Sydenham's chorea is a movement disorder that causes children's faces, hands, and feet to move quickly and uncontrollably, and can also affect mood and concentration. The physical recovery from Sydenham's chorea can take two to six months but the mental recovery (e.g. mood and concentration) can take longer to resolve. Sydenham's chorea remains endemic in Maori, Pacific Islander, Aboriginal and Torres Strait Islander children in New Zealand and Australia. There is limited evidence to direct treatment of Sydenham's chorea, and clinical practice differs widely around the world. Dexamethasone is an oral steroid which targets the abnormal immune response and successfully treats other immune-mediated brain disorders, with good tolerability. TREAT-SC is a randomized, double-blinded, placebo-controlled trial which will investigate whether a three day course of oral dexamethasone safely and effectively treats the movement disorder and psychiatric symptoms of Sydenham's chorea. The trial will recruit 80 participants from study sites in Australia and New Zealand.
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Trial website
https://clinicaltrials.gov/study/NCT06259006
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Hannah F Jones, MBChB PhD
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Address
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Starship Child Health, Te Whatu Ora Health New Zealand
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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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Hannah F Jones, MBChB PhD
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Address
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Country
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Phone
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+64 9 307 4949
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
De-identified data would be shared with researchers conducting meta-analysis study if robust research plan is provided and request emailed to PI.
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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/NCT06259006