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

Study acronym: TREAT-SC
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 17
    • Start date changed from estimate of May 2024 to Jun 17, 2024
    • Secondary endpoints: 8 to 7
    v4
  2. Notable Start date: Mar 2024 to May 2024v3 Show 4 more changesShow less
    • Primary completion date: Mar 2027 to May 2027
    • Study completion date: Mar 2028 to May 2028
    • Eligibility criteria expanded, about 56 words
    • Study description shortened, about 1 word
  3. Minor Eligibility criteria revised
    • Secondary endpoints: details revised at 3 of 8 entries
    • Study description expanded, about 14 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06259006
Lead Sponsor Starship Child Health, Te Toka Tumai Auckland
Collaborators: Health Research Council, New Zealand, Menzies School of Health Research
Conditions
(from sponsor)
Rheumatic Fever, Sydenham Chorea
Related terms Chorea, Rheumatic Fever
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov