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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/NCT06259006




Registration number
NCT06259006
Ethics application status
Date submitted
22/01/2024
Date registered
14/02/2024
Date last updated
11/04/2024

Titles & IDs
Public title
TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
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
Secondary ID [1] 0 0
StarshipChild
Universal Trial Number (UTN)
Trial acronym
TREAT-SC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatic Fever 0 0
Sydenham Chorea 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Infection 0 0 0 0
Other infectious diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Chorea severity at 1 month
Timepoint [1] 0 0
1 month
Secondary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
3 days, 7 days, 1 month
Secondary outcome [2] 0 0
Chorea severity
Timepoint [2] 0 0
7 days, 3 months, 12 months
Secondary outcome [3] 0 0
Total hospital length of stay
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Treatment failure at 14 days
Timepoint [4] 0 0
14 days
Secondary outcome [5] 0 0
Use of adjunctive chorea treatments
Timepoint [5] 0 0
1 month
Secondary outcome [6] 0 0
Chorea relapse and recurrence
Timepoint [6] 0 0
3 and 12 months
Secondary outcome [7] 0 0
Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale Subscores.
Timepoint [7] 0 0
7 days, 1 month, 3 months, 12 months
Secondary outcome [8] 0 0
Psychiatric symptoms
Timepoint [8] 0 0
1 month, 3 months and 12 months

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
Minimum age
4 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2028
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Northern Territorie
Recruitment hospital [1] 0 0
Royal Darwin Hospital - Darwin
Recruitment postcode(s) [1] 0 0
0810 - Darwin
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Starship Child Health, Te Toka Tumai Auckland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council, New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Menzies School of Health Research
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06259006
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hannah F Jones, MBChB PhD
Address 0 0
Starship Child Health, Te Whatu Ora Health New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hannah F Jones, MBChB PhD
Address 0 0
Country 0 0
Phone 0 0
+64 9 307 4949
Fax 0 0
Email 0 0
hannahj1@adhb.govt.nz
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06259006