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Pediatric Research Program

Our Neuroimmunology Research Group has partnered with Rady Children's Hospital, where Dr. Jennifer Graves runs a pediatric MS neurology clinic, to investigate MS and related diseases in children.

TRAC Peds MS Study

This is a non-interventional, minimal risk study involving the creation of a biospecimen repository and a database of clinically-acquired information about a cohort of pediatric multiple sclerosis (MS) and related diseases (i.e. MOGAD, NMOSD, Optic Neuritis, NMDAR, etc.) patients from the University of California, San Diego (UCSD) and Rady Children’s Hospital neurology clinics. 

Enrollment Information: This study is open for enrollment. Please contact: Sophie Zacharek. 

NEOS Study

The purpose of the research is to look at the safety, effectiveness, and tolerability of study drugs, ofatumumab and siponimod, compared to fingolimod, in children with relapsing remitting Multiple Sclerosis aged 10-18 years old. There is an unmet medical need in children who have Multiple Sclerosis. Fingolimod is currently the only approved MS medication for pediatric Multiple Sclerosis patients in the United States. Ofatumumab and siponimod work well in adults, and we want to see if it also works in children by reducing the number of MS relapses.  The primary objective of this study is to demonstrate the non-inferiority of ofatumumab and siponimod compared to fingolimod. This will be assessed through the annual MS relapse rate, or ARR. The secondary objectives are to demonstrate the superiority of the study drugs compared to historical inferferon beta-1a; to evaluate the effects, PK properties, and safety/tolerability of ofatumumab and siponimod; and to evaluate how effective ofatumumab is at producing an immune response.

Enrollment Information: This study is open for enrollment. Please contact: Sophie Zacharek. 

 

OPERETTA 2 Study

The purpose of the research is to evaluate the safety and efficacy of ocrelizumab compared to fingolimod in children and adolescents with relapsing-remitting multiple sclerosis. There is an unmet medical need in children who have Multiple Sclerosis. Fingolimod is currently one of the only approved MS medications for pediatric Multiple Sclerosis patients in the United States. Ocrelizumab has been studied in adult MS populations and has shown superior outcomes compared to other drugs, and we want to see if it also works in children by reducing the number of MS relapses. Ocrelizumab is a recombinant monoclonal antibody that depletes clusters of CD20 expressing B cells. This current study is a phase 3, randomized, double-blind, double-dummy, and multi-center study consisting of a screening period, a double blind period, an optional open-label extension period, and a safety follow-up period.  Unlike adults with MS, 95% of children with MS have relapsing-remitting MS. Therefore, studying ocrelizumab in children/adolescents with RRMS is important for scientific research.

Enrollment Information: This study is open for enrollment. Please contact: Sophie Zacharek. 

CONNECT Study

We propose the establishment of a multi-center collaborative research group on neuro-inflammatory conditions to better understand their natural history, diagnostic and treatment approaches, and long-term outcomes. Initial diseases included will be seropositive autoimmune encephalitis, Rasmussen encephalitis, and Landau Kleffner syndrome, in addition to other neuroinflammatory syndromes. Our overarching hypothesis is that these syndromes result in long-term sequelae, including risk for refractory seizures and poor neuropsychological outcomes, that may be mitigated by novel, early immunotherapies. The aim of this study is to perform a review of the clinical features and diagnostic studies of patients with neuroinflammatory disease to better understand the clinical course and treatment response. To further elucidate the underlying mechanisms of a given disease, we will also collect biospecimens for future biomarker discovery, immunophenotyping, and genetic analysis.

Enrollment Information: This study is open for enrollment. Please contact: Sophie Zacharek. 

 

Diet and Relapse Study

The Diet and Relapses Study is a pediatric study exploring the connection between rate of relapse and diet through the gut microbiome and amino acids found in the digestive tract. We hope to uncover the role that 25 (OH) vitamin D levels, fat and vegetable intake, and other nutrients take in the pediatric disease course, and to investigate the biological pathways relevant to this association.

Optional: By filling out a set of questionnaires, and a small blood draw, patients can help us to further understand pediatric MS.

PeMSDD Database Registry Study

PeMSDD is a database registry study linked to the Diet and Relapses study. This registry strives to describe the number and characteristics of patients with suspected early onset demyelinating disases. This database will help investigators allied with the National Pediatric MS Center to support hypothesis generation, and study design development.