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Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Cape Town.
Recruitment status was  Recruiting
Natal Bioproducts Institute
Information provided by:
University of Cape Town Identifier:
First received: February 1, 2008
Last updated: February 24, 2008
Last verified: February 2008

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 Intervention
Sydenham Chorea
Post Streptococcal Movement Disorder
Biological: Intravenous immunoglobulin
Drug: standard interventions penicillin VK and haloperidol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea

Resource links provided by NLM:

Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • improved scores on the sydenham chorea assessment charts [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • improved quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: May 2002
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00615797

Contact: Kathleen Walker, MB ChB 27 21 658 5111 ext 5434
Contact: Jo M Wilmshurst, MB BS MRCP FCP 27 21 658 5111 ext 5370

South Africa
Red Cross Children's Hospital Recruiting
Cape Town, Western Cape, South Africa, 7700
Contact: Kathleen Walker, Mb ChB    27 21 658 5111 ext 5424   
Contact: Jo M Wilmshurst, FCP    27 21 658 5111 ext 5434   
Principal Investigator: Kathleen Walker, Mb ChB         
Sponsors and Collaborators
University of Cape Town
Natal Bioproducts Institute
Principal Investigator: Kathleen Walker, MB ChB Red Cross Children's Hospital, University of Cape Town
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Kathleen Walker, Red Cross Childrens' Hospital, University of Cape Town Identifier: NCT00615797     History of Changes
Other Study ID Numbers: CTXO1-2002, REF049/2002
Study First Received: February 1, 2008
Last Updated: February 24, 2008
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Haloperidol decanoate
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Anti-Dyskinesia Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses processed this record on November 25, 2014