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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-17
SponsorStarship Child Health, Te Toka Tumai Auckland

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: DexamethasoneExperimental treatment 1 intervention
Group B: Placebo controlPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
1 month

Secondary outcomes

1

Chorea severity

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.

Time frame
7 days, 3 months, 12 months
2

Total hospital length of stay

Total hospital length of stay for chorea at three months

Time frame
3 months
3

Treatment failure at 14 days

Number of participants with treatment failure at 14 days

Time frame
14 days
4

Use of adjunctive chorea treatments

Number of participants treated with adjunctive chorea treatments

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Starship Child Health, Te Toka Tumai Auckland

Lead sponsor

Health Research Council, New Zealand

Collaborator

Menzies School of Health Research

Collaborator