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

NCT06259006 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: StarshipChild
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 17

Brief 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.

Conditions

Rheumatic Fever; Sydenham Chorea

Keywords

Sydenham Chorea

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month

Secondary Outcomes (7)

• Chorea severity

  7 days, 3 months, 12 months

• Total hospital length of stay

  3 months

• Treatment failure at 14 days

  14 days

• Use of adjunctive chorea treatments

  1 month

• Chorea relapse and recurrence

  3 and 12 months

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Participants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days

Drug: Dexamethasone Oral

Placebo control

PLACEBO COMPARATOR

Participants will receive oral placebo tablet three times a day for 3 days

Drug: Placebo

Interventions

Dexamethasone Oral DRUG

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

Dexamethasone

Placebo DRUG

Matching capsules taken orally three times daily for three days

Placebo control

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Starship Child Health, Te Toka Tumai Auckland: lead
• Health Research Council, New Zealand: collaborator
• Menzies School of Health Research: collaborator

Study Sites (17)

Royal Darwin Hospital

Darwin, Northern Territories, 0810, Australia

RECRUITING

KidzFirst Hospital

Auckland, New Zealand

RECRUITING

Starship Child Health, Te Toka Tumai, Auckland

Auckland, New Zealand

RECRUITING

Waitākere Hospital

Auckland, New Zealand

RECRUITING

Gisborne Hospital

Gisborne, New Zealand

RECRUITING

Waikato Hospital

Hamilton, New Zealand

RECRUITING

Hawkes Bay Fallen Soldiers' Memorial Hospital

Hastings, New Zealand

RECRUITING

Hutt Hospital

Lower Hutt, New Zealand

RECRUITING

Wairarapa Hospital

Masterton, New Zealand

RECRUITING

Taranaki Base Hospital

New Plymouth, New Zealand

RECRUITING

Palmerston North Hospital

Palmerston North, New Zealand

RECRUITING

Rotorua Hospital

Rotorua, New Zealand

RECRUITING

Tauranga Hospital

Tauranga, New Zealand

RECRUITING

Wellington Regional Hospital

Wellington, New Zealand

RECRUITING

Whakatāne Hospital

Whakatāne, New Zealand

RECRUITING

Whanganui Hospital

Whanganui, New Zealand

RECRUITING

Whangārei Hospital

Whangarei, New Zealand

RECRUITING

MeSH Terms

Conditions

Rheumatic Fever; Chorea

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hannah F Jones, MBChB PhD

  Starship Child Health, Te Whatu Ora Health New Zealand

  PRINCIPAL INVESTIGATOR

• Kathryn V Roberts, MBBS PhD

  Royal Darwin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah F Jones, MBChB PhD

CONTACT

+64 9 307 4949; hannahj1@adhb.govt.nz

Starship Research Office

CONTACT

+64 21 369 340; starshipresearch@adhb.govt.nz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding will be achieved by over-encapsulation of tablets so that placebo cannot be distinguished from dexamethasone
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paediatric Neurologist, Principal Investigator

Model Details: Participants will be randomised and allocated 1:1 to blinded dexamethasone or placebo groups.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: February 14, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NZ (16)