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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
Sponsor:
Collaborator:
Natal Bioproducts Institute
Information provided by:
University of Cape Town
ClinicalTrials.gov Identifier:
NCT00615797
First received: February 1, 2008
Last updated: February 24, 2008
Last verified: February 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615797

Contacts
Contact: Kathleen Walker, MB ChB 27 21 658 5111 ext 5434 buley@iafrica.com
Contact: Jo M Wilmshurst, MB BS MRCP FCP 27 21 658 5111 ext 5370 jo.wilmshurst@uct.ac.za

Locations
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     buley@iafrica.com    
Contact: Jo M Wilmshurst, FCP     27 21 658 5111 ext 5434     jo.wilmshurst@uct.ac.za    
Principal Investigator: Kathleen Walker, Mb ChB            
Sponsors and Collaborators
University of Cape Town
Natal Bioproducts Institute
Investigators
Principal Investigator: Kathleen Walker, MB ChB Red Cross Children's Hospital, University of Cape Town
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Kathleen Walker, Red Cross Childrens' Hospital, University of Cape Town
ClinicalTrials.gov 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:
Chorea
Movement Disorders
Dyskinesias
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Penicillin V
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013