Study of Cytokines in Children With Opsoclonus-Myoclonus Syndrome (OMS)
|ClinicalTrials.gov Identifier: NCT00806182|
Recruitment Status : Completed
First Posted : December 10, 2008
Last Update Posted : May 23, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||400 participants|
|Official Title:||Cytokines as Biomarkers and Therapeutic Targets in Paraneoplastic Opsoclonus-Myoclonus Syndrome (OMS)|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
These are children who underwent lumbar puncture and blood drawing for diagnostic testing for non-inflammatory neurological or non-neurological disorders, and whose samples were retrieved from the clinical lab under a linked Institutional Review Board (IRB) protocol.
These are patients treated by the P.I. based on clinical decision making, not a clinical trial (this is an observational study). The types of treatments are varied, and, on the initial evaluation, the patients may be untreated or already tried on various immunotherapies. They range from monotherapy with steroids, ACTH, or IVIg, to disease modifying agents, such as rituximab, cyclophosphamide, and other chemotherapy, typically adjunctively or as combination therapy.
- Reduction in inflammatory cytokines [ Time Frame: 6 and 12 months ]Reduction in the concentration of inflammatory chemokines/cytokines between clinical time points
- Correlation of cytokine concentration and clinical severity score. [ Time Frame: 6 and 12 months ]Statistical correlation of chemokine/cytokine concentration with OMS motor severity as measured using the OMS video evaluation scale
Biospecimen Retention: Samples Without DNA
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 ClinicalTrials.gov identifier (NCT number): NCT00806182
|United States, Illinois|
|National Pediatric Myoclonus Center, Formerly at Dept. of Neurology, Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|Principal Investigator:||Michael R Pranzatelli, MD||National Pediatric Neuroinflammation Organization, Inc.|
|Study Director:||Elizabeth D Tate, FNP, MN||National Pediatric Neuroinflammation Organization, Inc.|