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NCT Number: NCT06259006

TREAT-SC: 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.

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Key information

Conditions

Rheumatic Fever Arthritis Bacterial Infections Bacterial Infections and Mycoses Central Nervous System Diseases Chorea Connective Tissue Diseases Dyskinesias Gram-Positive Bacterial Infections Infections Joint Diseases Movement Disorders Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Skin and Connective Tissue Diseases Streptococcal Infections Sydenham Chorea

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Darwin Hospital, Darwin, Northern Territories, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Dexamethasone Oral

Drug

Dexamethasone suspension (1mg/ml) 20mg/m2/day (maximum dose 24mg/day) given in three divided doses

Placebo

Drug

Matching capsules taken orally three times daily for three days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Total hospital length of stay

    Time frame: 3 months

    Total hospital length of stay for chorea at three months

  3. Treatment failure at 14 days

    Time frame: 14 days

    Number of participants with treatment failure at 14 days

  4. Use of adjunctive chorea treatments

    Time frame: 1 month

    Number of participants treated with adjunctive chorea treatments

  5. Chorea relapse and recurrence

    Time frame: 3 and 12 months

    Number of participants with chorea relapse and recurrence at 3 and 12 months

  6. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah F Jones, MBChB PhD

CONTACT

[email protected]

+64 9 307 4949

Starship Research Office

CONTACT

[email protected]

+64 21 369 340

Sponsors and collaborators

Lead sponsor

Starship Child Health, Te Toka Tumai Auckland

Other Gov

Collaborators

  • Health Research Council, New Zealand
  • Menzies School of Health Research

Registry information

Official study title

TREAT-SC: A Randomised, Double-Blinded, Placebo-Controlled Trial of Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children

Acronym: TREAT-SC

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 14, 2024
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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