Rheumatic FeverPhase 3TREAT-SCNCT06259006
TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
A Phase 3 study testing Dexamethasone Oral in people with Rheumatic Fever and Sydenham Chorea, run by Starship Child Health, Te Toka Tumai Auckland at 17 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Rheumatic Fever, Sydenham Chorea
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 17 Jun 2024to May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sydenham's chorea of any severity diagnosed by a paediatrician or neurologist based on national ARF guidelines
- Child or adolescents aged 4 years to <18 years of age
Who cannot join
- Administered steroids or intravenous immunoglobulin since onset of the current Sydenham's chorea episode
- Evidence of concomitant severe, acute infection
- History of hypersensitivity to dexamethasone or its excipients
- Pregnancy
- Confirmed exposure of an unimmunised child to measles, mumps, rubella or chickenpox within the previous four weeks
- Receipt of a live vaccine within the previous four weeks
- Medical condition or treatment with medication which in the opinion of the trial investigators would make the child unsuitable for the trial
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
New Zealand16 sites, 16 recruiting
- Recruiting
KidzFirst Hospital
Auckland
Dr Adam Dennison, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Adam Dennison
- Recruiting
Starship Child Health, Te Toka Tumai, Auckland
Auckland
Hannah F Jones, +64 9 307 4931, treatsc@adhb.govt.nz
Hannah F Jones
- Recruiting
Waitākere Hospital
Auckland
Dr Rebecca Somerville, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Rebecca Somerville
- Recruiting
Gisborne Hospital
Gisborne
Dr Shaun Grant, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Shaun Grant
- Recruiting
Waikato Hospital
Hamilton
Dr Te Aro Moxon, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Te Aro Moxon
- Recruiting
Hawkes Bay Fallen Soldiers' Memorial Hospital
Hastings
Dr Kai Steinmann, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Kai Steinmann
- Recruiting
Hutt Hospital
Lower Hutt
Dr Erik Andersen
Dr Erik Andersen
- Recruiting
Wairarapa Hospital
Masterton
Dr Liza Edmonds, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Liza Edmonds
- Recruiting
Taranaki Base Hospital
New Plymouth
Dr Emma Cluett, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Emma Cluett
- Recruiting
Palmerston North Hospital
Palmerston North
Dr Lydia Elshoff, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Lydia Elshoff
- Recruiting
Rotorua Hospital
Rotorua
Dr Danny de Lore, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Danny de Lore
- Recruiting
Tauranga Hospital
Tauranga
Dr Joshua Agnew, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Joshua Agnew
- Recruiting
Wellington Regional Hospital
Wellington
Dr Erik Andersen, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Erik Andersen
- Recruiting
Whakatāne Hospital
Whakatāne
Dr Michael Herd, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Michael Herd
- Recruiting
Whanganui Hospital
Whanganui
Dr How Koh, +64 9 307 4931, treatsc@adhb.govt.nz
Dr How Koh
- Recruiting
Whangārei Hospital
Whangarei
Dr Ailsa Tuck, +64 9 307 4931, treatsc@adhb.govt.nz
Dr Ailsa Tuck
Australia1 site, 1 recruiting
- Recruiting
Royal Darwin Hospital
Darwin, Northern Territories, 0810
Kathryn V Roberts
Kathryn V Roberts
About this study
Official title: TREAT-SC: A Randomised, Double-Blinded, Placebo-Controlled Trial of Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
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 Māori, Pacific Islander, Aboriginal and Torres Strait Islander children in New Zealand and Australia.
Read more
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.
Read the detailed description
Aim: The aim of the trial is to determine whether an early, short course of oral dexamethasone is a safe and effective treatment to reduce morbidity associated with Sydenham's chorea in New Zealand and Australian children.
Objectives:
- The primary objective is to determine whether oral dexamethasone is an effective treatment to reduce Sydenham's chorea severity in New Zealand and Australian children at one month
- The secondary objectives are to determine whether oral dexamethasone is an effective treatment to reduce Sydenham's chorea severity at different time points, relapse and recurrence rates at three and 12 months, total hospital length of stay at three months, treatment failure at 14 days, use of adjunctive chorea treatments, Universidade Federal de Minas Gerais (UFMG) Sydenham's Chorea Rating Scale (USCRS) subscores, and psychiatric symptoms scored by the Strengths and Difficulties Questionnaire at one, three and 12 months. The safety of oral dexamethasone use will be assessed at study visits on days three and seven and at one month to monitor for any adverse events which may relate to dexamethasone use.
Research Design: TREAT-SC is a pragmatic parallel-group, double-blinded, placebo-controlled, 1:1 randomized efficacy trial comparing a three-day course of oral dexamethasone with placebo to treat Sydenham's chorea in New Zealand and Australian children. TREAT-SC will be a multi-site trial with participants recruited from hospitals in New Zealand and Australia.
- Conditions
- Rheumatic Fever, Sydenham Chorea
- Being tested
- Dexamethasone Oral, Placebo
- Keywords
- Sydenham Chorea
- Medical subject headings
- Rheumatic Fever, Chorea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
Dexamethasone suspension (1mg/ml) 20mg/m2/day (maximum dose 24mg/day) given in three divided doses
PlaceboDrug
Matching capsules taken orally three times daily for three days
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Participants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days Receives: Drug: Dexamethasone Oral |
| Placebo control | Placebo comparator | Participants will receive oral placebo tablet three times a day for 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chorea severity at 1 month
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.
Measured: 1 month
Secondary outcomes (7)
Chorea severity
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.
Measured: 7 days, 3 months, 12 months
Total hospital length of stay
Total hospital length of stay for chorea at three months
Measured: 3 months
Treatment failure at 14 days
Number of participants with treatment failure at 14 days
Measured: 14 days
Use of adjunctive chorea treatments
Number of participants treated with adjunctive chorea treatments
Measured: 1 month
Chorea relapse and recurrence
Number of participants with chorea relapse and recurrence at 3 and 12 months
Measured: 3 and 12 months
Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale Subscores.
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.
Measured: 7 days, 1 month, 3 months, 12 months
Psychiatric symptoms
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.
Measured: 1 month, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start17 Jun 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised and allocated 1:1 to blinded dexamethasone or placebo groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starship Child Health, Te Toka Tumai Auckland
- Sponsor type
- Other government
- Collaborators
- Health Research Council, New Zealand, Menzies School of Health Research
- Responsible party
- Principal investigator, Hannah F Jones, MD, Starship Child Health, Te Toka Tumai Auckland
- Investigators
- Hannah F Jones, MBChB PhD, Principal investigator, Starship Child Health, Te Whatu Ora Health New ZealandKathryn V Roberts, MBBS PhD, Principal investigator, Royal Darwin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259006
- Sponsor's protocol ID
- StarshipChild
- Acronym
- TREAT-SC
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data would be shared with researchers conducting meta-analysis study if robust research plan is provided and request emailed to PI.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TREAT-SC: A Randomised, Double-Blinded, Placebo-Controlled Trial of Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
- ClinicalTrials.gov ID
- NCT06259006
- Acronym / sponsor ID
- TREAT-SC / StarshipChild
- Conditions
- Rheumatic Fever, Sydenham Chorea
- Keywords
- Sydenham Chorea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Starship Child Health, Te Toka Tumai AucklandOther government
- Collaborators
- Health Research Council, New Zealand, Menzies School of Health Research
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Māori, 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.
Detailed description
Aim: The aim of the trial is to determine whether an early, short course of oral dexamethasone is a safe and effective treatment to reduce morbidity associated with Sydenham's chorea in New Zealand and Australian children.
Objectives:
- The primary objective is to determine whether oral dexamethasone is an effective treatment to reduce Sydenham's chorea severity in New Zealand and Australian children at one month
- The secondary objectives are to determine whether oral dexamethasone is an effective treatment to reduce Sydenham's chorea severity at different time points, relapse and recurrence rates at three and 12 months, total hospital length of stay at three months, treatment failure at 14 days, use of adjunctive chorea treatments, Universidade Federal de Minas Gerais (UFMG) Sydenham's Chorea Rating Scale (USCRS) subscores, and psychiatric symptoms scored by the Strengths and Difficulties Questionnaire at one, three and 12 months. The safety of oral dexamethasone use will be assessed at study visits on days three and seven and at one month to monitor for any adverse events which may relate to dexamethasone use.
Research Design: TREAT-SC is a pragmatic parallel-group, double-blinded, placebo-controlled, 1:1 randomized efficacy trial comparing a three-day course of oral dexamethasone with placebo to treat Sydenham's chorea in New Zealand and Australian children. TREAT-SC will be a multi-site trial with participants recruited from hospitals in New Zealand and Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomised and allocated 1:1 to blinded dexamethasone or placebo groups.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone OralParticipants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days |
| Placebo control | Placebo comparator | Drug: PlaceboParticipants will receive oral placebo tablet three times a day for 3 days |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Sydenham's chorea of any severity diagnosed by a paediatrician or neurologist based on national ARF guidelines
- Child or adolescents aged 4 years to <18 years of age
Key exclusion criteria (7 listed)
- Administered steroids or intravenous immunoglobulin since onset of the current Sydenham's chorea episode
- Evidence of concomitant severe, acute infection
- History of hypersensitivity to dexamethasone or its excipients
- Pregnancy
- Confirmed exposure of an unimmunised child to measles, mumps, rubella or chickenpox within the previous four weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone OralDexamethasone suspension (1mg/ml) 20mg/m2/day (maximum dose 24mg/day) given in three divided doses | Drug | Dexamethasone |
| PlaceboMatching capsules taken orally three times daily for three days | Drug | Placebo control |
Primary outcome
Chorea severity at 1 month
Time frame: 1 month
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.
7 secondary outcomes
Chorea severity
Time frame: 7 days, 3 months, 12 months
Total hospital length of stay
Time frame: 3 months
Treatment failure at 14 days
Time frame: 14 days
Use of adjunctive chorea treatments
Time frame: 1 month
Chorea relapse and recurrence
Time frame: 3 and 12 months
Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale Subscores.
Time frame: 7 days, 1 month, 3 months, 12 months
Psychiatric symptoms
Time frame: 1 month, 3 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hannah F Jones, MBChB PhD principal investigator
Starship Child Health, Te Whatu Ora Health New Zealand
Kathryn V Roberts, MBBS PhD principal investigator
Royal Darwin Hospital
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone Oral in people with Rheumatic Fever and Sydenham Chorea, run by Starship Child Health, Te Toka Tumai Auckland at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in New Zealand, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah F Jones, MBChB PhD (+64 9 307 4949, hannahj1@adhb.govt.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chorea severity at 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.