TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children (TREAT-SC)

June 17, 2025 updated by: Hannah F Jones, MD, Starship Child Health, Te Toka Tumai Auckland

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Northern Territories
      • Darwin, Northern Territories, Australia, 0810
        • Recruiting
        • Royal Darwin Hospital
        • Contact:
          • Kathryn V Roberts
        • Principal Investigator:
          • Kathryn V Roberts
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • KidzFirst Hospital
        • Contact:
        • Principal Investigator:
          • Dr Adam Dennison
      • Auckland, New Zealand
        • Recruiting
        • Starship Child Health, Te Toka Tumai, Auckland
        • Contact:
        • Principal Investigator:
          • Hannah F Jones
      • Auckland, New Zealand
        • Recruiting
        • Waitakere Hospital
        • Contact:
        • Principal Investigator:
          • Dr Rebecca Somerville
      • Gisborne, New Zealand
        • Recruiting
        • Gisborne Hospital
        • Contact:
        • Principal Investigator:
          • Dr Shaun Grant
      • Hamilton, New Zealand
        • Recruiting
        • Waikato Hospital
        • Contact:
        • Principal Investigator:
          • Dr Te Aro Moxon
      • Hastings, New Zealand
        • Recruiting
        • Hawkes Bay Fallen Soldiers' Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Dr Kai Steinmann
      • Lower Hutt, New Zealand
        • Recruiting
        • Hutt Hospital
        • Contact:
          • Dr Erik Andersen
        • Principal Investigator:
          • Dr Erik Andersen
      • Masterton, New Zealand
        • Recruiting
        • Wairarapa Hospital
        • Contact:
        • Principal Investigator:
          • Dr Liza Edmonds
      • New Plymouth, New Zealand
        • Recruiting
        • Taranaki Base Hospital
        • Contact:
        • Principal Investigator:
          • Dr Emma Cluett
      • Palmerston North, New Zealand
        • Recruiting
        • Palmerston North Hospital
        • Contact:
        • Principal Investigator:
          • Dr Lydia Elshoff
      • Rotorua, New Zealand
        • Recruiting
        • Rotorua Hospital
        • Contact:
        • Principal Investigator:
          • Dr Danny de Lore
      • Tauranga, New Zealand
        • Recruiting
        • Tauranga Hospital
        • Contact:
        • Principal Investigator:
          • Dr Joshua Agnew
      • Wanganui, New Zealand
        • Recruiting
        • Whanganui Hospital
        • Contact:
        • Principal Investigator:
          • Dr How Koh
      • Wellington, New Zealand
        • Recruiting
        • Wellington Regional Hospital
        • Principal Investigator:
          • Dr Erik Andersen
        • Contact:
      • Whakatāne, New Zealand
        • Recruiting
        • Whakatāne Hospital
        • Contact:
        • Principal Investigator:
          • Dr Michael Herd
      • Whangarei, New Zealand
        • Recruiting
        • Whangarei Hospital
        • Contact:
        • Principal Investigator:
          • Dr Ailsa Tuck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
Participants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days
Drug: Dexamethasone Oral
Dexamethasone suspension (1mg/ml) 20mg/m2/day (maximum dose 24mg/day) given in three divided doses
Placebo Comparator: Placebo control
Participants will receive oral placebo tablet three times a day for 3 days
Drug: Placebo
Matching capsules taken orally three times daily for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chorea severity
Time Frame: 7 days, 3 months, 12 months
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 days, 3 months, 12 months
Total hospital length of stay
Time Frame: 3 months
Total hospital length of stay for chorea at three months
3 months
Universidade Federal de Minas Gerais Sydenham's Chorea Rating Scale Subscores.
Time Frame: 7 days, 1 month, 3 months, 12 months
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.
7 days, 1 month, 3 months, 12 months
Psychiatric symptoms
Time Frame: 1 month, 3 months and 12 months
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.
1 month, 3 months and 12 months
Treatment failure at 14 days
Time Frame: 14 days
Number of participants with treatment failure at 14 days
14 days
Use of adjunctive chorea treatments
Time Frame: 1 month
Number of participants treated with adjunctive chorea treatments
1 month
Chorea relapse and recurrence
Time Frame: 3 and 12 months
Number of participants with chorea relapse and recurrence at 3 and 12 months
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Starship Child Health, Te Toka Tumai Auckland

Collaborators

Menzies School of Health Research
Health Research Council, New Zealand

Investigators

  • Principal Investigator: Hannah F Jones, MBChB PhD, Starship Child Health, Te Whatu Ora Health New Zealand
  • Principal Investigator: Kathryn V Roberts, MBBS PhD, Royal Darwin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StarshipChild

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data would be shared with researchers conducting meta-analysis study if robust research plan is provided and request emailed to PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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