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Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00615797
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : December 4, 2014
Natal Bioproducts Institute
Information provided by (Responsible Party):
Jo M Wilmshurst, University of Cape Town

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.

Condition or disease Intervention/treatment Phase
Sydenham Chorea Post Streptococcal Movement Disorder Biological: Intravenous immunoglobulin Drug: standard interventions penicillin VK and haloperidol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea
Study Start Date : May 2002
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1
Group randomized to receive intravenous immunoglobulins in addition to standard therapy for sydenham's chorea
Biological: Intravenous immunoglobulin
intravenous immunoglobulin 2g/kg total given over 2 days

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

Primary Outcome Measures :
  1. improved scores on the sydenham chorea assessment charts [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. improved quality of life [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00615797

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South Africa
Red Cross Children's Hospital
Cape Town, Western Cape, South Africa, 7700
Sponsors and Collaborators
University of Cape Town
Natal Bioproducts Institute
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Principal Investigator: Kathleen Walker, MB ChB Red Cross Children's Hospital, University of Cape Town
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jo M Wilmshurst, Prof, University of Cape Town Identifier: NCT00615797    
Other Study ID Numbers: CTXO1-2002
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Penicillin V
Haloperidol decanoate
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents