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Sydenham Chorea | Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea

Sydenham Chorea research study

What is the primary objective of this study?

Children are at risk of developing an involuntary movement disorder after streptococcal throat infections. Not all children are affected and the severity is individually variable. Affected children have alteration in their behaviour and mood and can become quite compromised in their activities of daily living. The condition is believed to be related to the body having an over efficient immune response to the infection and some of the antibodies made in response to the infection also \"attack\" centres in the brain controlling movement and mood. Treating these children with immunoglobulins, which \"mop up\" the antibodies may reverse or improve affected children. This study hopes to clarify this.

Who is eligible to participate?

Inclusion Criteria: - Sydenham chorea moderate to severe (affecting activities of daily living) Raised ASOT titre Exclusion Criteria: - Mild Sydenham chorea (not affecting activities of daily living) - Exclusion of systemic lupus erythematosus - Exclusion of Wilson's disease - Exclusion of toxin ingestion

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sydenham Chorea

Post Streptococcal Movement Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Intravenous immunoglobulinintravenous immunoglobulin 2g/kg total given over 2 days

Drug:standard interventions penicillin VK and haloperidolPenicillin V K 500mg 12hrly po or 250mg 6 hrly for 10 days IM penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG haloperidol 0,025mg/kg/day orally in divided doses gradually increasing to a maximum of 0,05mg/kg/day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Group randomized to receive intravenous immunoglobulins in addition to standard therapy for sydenham's chorea

2Group randomized to receive standard intervention for sydenham's chorea alone

Study Status

Completed

Start Date: May 2002

Completed Date: December 2009

Phase: N/A

Type: Interventional

Design:

Primary Outcome: improved scores on the sydenham chorea assessment charts

Secondary Outcome: improved quality of life

Study sponsors, principal investigator, and references

Principal Investigator: Kathleen Walker, MB ChB

Lead Sponsor: University of Cape Town

Collaborator: Natal Bioproducts Institute

More information:https://clinicaltrials.gov/show/NCT00615797

Perlmutter SJ, Leitman SF, Garvey MA, Hamburger S, Feldman E, Leonard HL, Swedo SE. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999 Oct 2;354(9185):1153-8.

Discuss Penicillin