drugset / Trial / NCT00615797
Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2002-05
- Primary completion
- 2009-12
- Completion
- 2009-12
Publications
- Background Perlmutter SJ, Leitman SF, Garvey MA, Hamburger S, Feldman E, Leonard HL, Swedo SE. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999 Oct 2;354(9185):1153-8. doi: 10.1016/S0140-6736(98)12297-3.
- Background Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.
- Background Barron KS, Sher MR, Silverman ED. Intravenous immunoglobulin therapy: magic or black magic. J Rheumatol Suppl. 1992 Apr;33:94-7.
- Gregorowski C, Lochner C, Martin L, Simmons C, Kidd M, Walker K, Wilmshurst JM, Seedat S. Neuropsychological manifestations in children with Sydenham's chorea after adjunct intravenous immunoglobulin and standard treatment. Metab Brain Dis. 2016 Feb;31(1):205-12. doi: 10.1007/s11011-015-9681-1. Epub 2015 May 19.
- Walker K, Brink A, Lawrenson J, Mathiassen W, Wilmshurst JM. Treatment of sydenham chorea with intravenous immunoglobulin. J Child Neurol. 2012 Feb;27(2):147-55. doi: 10.1177/0883073811414058. Epub 2011 Aug 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |
| Comparator | Haloperidol | Other / unclassified | 0.05 mg/kg | Oral |
| Comparator | Penicillin V | Small molecule | 250 mg | Oral |
| Comparator | Penicillin V | Small molecule | 500 mg | Oral |