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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Royal Darwin Hospital
RECRUITING
Darwin
New Zealand
KidzFirst Hospital
RECRUITING
Auckland
Starship Child Health, Te Toka Tumai, Auckland
RECRUITING
Auckland
Waitākere Hospital
RECRUITING
Auckland
Gisborne Hospital
RECRUITING
Gisborne
Waikato Hospital
RECRUITING
Hamilton
Hawkes Bay Fallen Soldiers' Memorial Hospital
RECRUITING
Hastings
Hutt Hospital
RECRUITING
Lower Hutt
Wairarapa Hospital
RECRUITING
Masterton
Taranaki Base Hospital
RECRUITING
New Plymouth
Palmerston North Hospital
RECRUITING
Palmerston North
Rotorua Hospital
RECRUITING
Rotorua
Tauranga Hospital
RECRUITING
Tauranga
Wellington Regional Hospital
RECRUITING
Wellington
Whakatāne Hospital
RECRUITING
Whakatāne
Whanganui Hospital
RECRUITING
Whanganui
Whangārei Hospital
RECRUITING
Whangarei
Contact Information
Primary
Hannah F Jones, MBChB PhD
hannahj1@adhb.govt.nz
+64 9 307 4949
Backup
Starship Research Office
starshipresearch@adhb.govt.nz
+64 21 369 340
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2028-05
Participants
Target number of participants: 80
Treatments
Experimental: Dexamethasone
Participants will receive oral dexamethasone 20mg/m2/day in three divided doses, (maximum dose 24mg/day), for 3 days
Placebo_comparator: Placebo control
Participants will receive oral placebo tablet three times a day for 3 days
Sponsors
Collaborators: Health Research Council, New Zealand, Menzies School of Health Research
Leads: Starship Child Health, Te Toka Tumai Auckland

This content was sourced from clinicaltrials.gov