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

Last updated: June 17, 2025
Sponsor: Starship Child Health, Te Toka Tumai Auckland
Overall Status: Active - Recruiting

Phase

3

Condition

Rheumatic Fever

Dystonia

Dyskinesias

Treatment

Placebo

Dexamethasone Oral

Clinical Study ID

NCT06259006
StarshipChild
  • Ages 4-17
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sydenham's chorea of any severity diagnosed by a paediatrician or neurologist basedon national ARF guidelines

  2. Child or adolescents aged 4 years to <18 years of age

Exclusion

Exclusion Criteria:

  1. Administered steroids or intravenous immunoglobulin since onset of the currentSydenham'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 chickenpoxwithin 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 trialinvestigators would make the child unsuitable for the trial

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
June 17, 2024
Estimated Completion Date:
May 31, 2028

Study 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.

Connect with a study center

  • Royal Darwin Hospital

    Darwin, Northern Territories 0810
    Australia

    Active - Recruiting

  • KidzFirst Hospital

    Auckland,
    New Zealand

    Active - Recruiting

  • Starship Child Health, Te Toka Tumai Auckland, Te Whatu Ora Health New Zealand

    Auckland,
    New Zealand

    Site Not Available

  • Starship Child Health, Te Toka Tumai, Auckland

    Auckland,
    New Zealand

    Active - Recruiting

  • Waitākere Hospital

    Auckland,
    New Zealand

    Active - Recruiting

  • Gisborne Hospital

    Gisborne,
    New Zealand

    Active - Recruiting

  • Waikato Hospital

    Hamilton,
    New Zealand

    Active - Recruiting

  • Hawkes Bay Fallen Soldiers' Memorial Hospital

    Hastings,
    New Zealand

    Active - Recruiting

  • Hutt Hospital

    Lower Hutt,
    New Zealand

    Active - Recruiting

  • Wairarapa Hospital

    Masterton,
    New Zealand

    Active - Recruiting

  • Taranaki Base Hospital

    New Plymouth,
    New Zealand

    Active - Recruiting

  • Palmerston North Hospital

    Palmerston North,
    New Zealand

    Active - Recruiting

  • Rotorua Hospital

    Rotorua,
    New Zealand

    Active - Recruiting

  • Tauranga Hospital

    Tauranga,
    New Zealand

    Active - Recruiting

  • Whanganui Hospital

    Wanganui,
    New Zealand

    Active - Recruiting

  • Wellington Regional Hospital

    Wellington,
    New Zealand

    Active - Recruiting

  • Whakatāne Hospital

    Whakatāne,
    New Zealand

    Active - Recruiting

  • Whangārei Hospital

    Whangarei,
    New Zealand

    Active - Recruiting

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