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| Sponsors and Collaborators: |
University of Cape Town Natal Bioproducts Institute |
|---|---|
| Information provided by: | University of Cape Town |
| ClinicalTrials.gov Identifier: | NCT00615797 |
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: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea |
| 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 |
|---|---|
|
1: Experimental
Group randomized to receive intravenous immunoglobulins in addition to standard therapy for sydenham's chorea
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Biological: Intravenous immunoglobulin
intravenous immunoglobulin 2g/kg total given over 2 days
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2: Placebo Comparator
Group randomized to receive standard intervention for sydenham's chorea alone
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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
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Show Detailed Description Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| South Africa, Western Cape | |
| 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 | |
| Principal Investigator: | Kathleen Walker, MB ChB | Red Cross Children's Hospital, University of Cape Town |
More Information
| Responsible Party: | Red Cross Childrens' Hospital, University of Cape Town ( Dr Kathleen Walker ) |
| Study ID Numbers: | CTXO1-2002, REF049/2002 |
| Study First Received: | February 1, 2008 |
| Last Updated: | February 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00615797 |
| Health Authority: | South Africa: Medicines Control Council |
|
Penicillin V Sydenham's chorea Central Nervous System Diseases Dyskinesias Chorea Haloperidol Signs and Symptoms Haloperidol decanoate |
Antibodies Dopamine Immunoglobulins, Intravenous Movement Disorders Chorea minor Rho(D) Immune Globulin Neurologic Manifestations Immunoglobulins |
|
Anti-Infective Agents Neurotransmitter Agents Tranquilizing Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics |
Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Anti-Bacterial Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |
