NCT00615797

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

7.6 years

First QC Date

February 1, 2008

Last Update Submit

December 3, 2014

Conditions

Sydenham ChoreaPost Streptococcal Movement Disorder

Outcome Measures

Primary Outcomes (1)

  • improved scores on the sydenham chorea assessment charts

    6 months

Secondary Outcomes (1)

  • improved quality of life

    2 years

Study Arms (2)

1

EXPERIMENTAL

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

Biological: Intravenous immunoglobulin

2

PLACEBO COMPARATOR

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

Drug: standard interventions penicillin VK and haloperidol

Interventions

Intravenous immunoglobulinBIOLOGICAL

intravenous immunoglobulin 2g/kg total given over 2 days

1
standard interventions penicillin VK and haloperidolDRUG

Penicillin 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

2

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Sydenham chorea moderate to severe (affecting activities of daily living) Raised ASOT titre

You may not qualify if:

  • Mild Sydenham chorea (not affecting activities of daily living)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Red Cross Children's Hospital

Cape Town, Western Cape, 7700, South Africa

Location

Related Publications (5)

  • 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. doi: 10.1016/S0140-6736(98)12297-3.

    PMID: 10513708BACKGROUND

  • Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.

    PMID: 7661914BACKGROUND

  • Barron KS, Sher MR, Silverman ED. Intravenous immunoglobulin therapy: magic or black magic. J Rheumatol Suppl. 1992 Apr;33:94-7.

    PMID: 1593608BACKGROUND

  • Gregorowski C, Lochner C, Martin L, Simmons C, Kidd M, Walker K, Wilmshurst JM, Seedat S. Neuropsychological manifestations in children with Sydenham's chorea after adjunct intravenous immunoglobulin and standard treatment. Metab Brain Dis. 2016 Feb;31(1):205-12. doi: 10.1007/s11011-015-9681-1. Epub 2015 May 19.

    PMID: 25987537DERIVED

  • Walker K, Brink A, Lawrenson J, Mathiassen W, Wilmshurst JM. Treatment of sydenham chorea with intravenous immunoglobulin. J Child Neurol. 2012 Feb;27(2):147-55. doi: 10.1177/0883073811414058. Epub 2011 Aug 24.

    PMID: 21868369DERIVED

MeSH Terms

Conditions

Chorea

Interventions

Immunoglobulins, IntravenousHaloperidol

Condition Hierarchy (Ancestors)

DyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Kathleen Walker, MB ChB

    Red Cross Children's Hospital, University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

May 1, 2002

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

ZA(1)