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Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea

NCT00615797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-12-04

No results posted yet for this study

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.

Conditions

  • Sydenham Chorea
  • Post Streptococcal Movement Disorder

Interventions

BIOLOGICAL

Intravenous immunoglobulin

intravenous immunoglobulin 2g/kg total given over 2 days

DRUG

standard interventions penicillin VK and haloperidol

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

Sponsors & Collaborators

  • Natal Bioproducts Institute

    collaborator UNKNOWN

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Kathleen Walker, MB ChB · Red Cross Children's Hospital, University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • South Africa

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00615797 on ClinicalTrials.gov