Clinical Trials Program

With a commitment to bring new therapies to our patients, we run a clinical trials program for MS and related diseases.

Currently Enrolling Studies

 Multisensors Multiple Sclerosis 

This is an investigation into the utilization of a multisensor to monitor for disease activity and progression in multiple sclerosis, and understanding how we can improve technology to better monitor and observe clinical progression in MS and related diseases. The main objectives of this study are to (1) use the multisensor and handtracking program to measure and quantify functional differences in MS patients vs. healthy controls; (2) use the multisensor and handtracking program to measure and quantify functional differences in MS patients in different disease states and as they progress clinically and (3) to improve the functionality of the multisensor and handtracking program for further use in research and clinical trials of neurodegenerative diseases. In order to meet these objectives, we plan to recruit 150 participants who have been diagnosed with MS or a related disease, and 50 healthy controls to function as a comparator group. This study will last about 5 years.

Enrollment Information:  This study is open for enrollment. Please contact Ashley Fair.

Neuroimaging in Aging and Multiple Sclerosis 

This is a cross-sectional investigation into neuroimaging in pediatric and adult onset multiple sclerosis, and understanding changes in the brain that happen as a result of biological aging and disease progression. The main objectives of this study are to (1) use neuroimaging techniques to understand biological implications of aging on MS disease progression and the brain; (2) determine if blood-brain barrier (BBB) permeability is associated with disease progression; (3) assess the association of BBB breakdown with brain morphometry and microstructure; and (4) evaluate BBB breakdown and RSI for sensitivity to MS progression. In order to meet these objectives, we plan to recruit 100 case participants who have been diagnosed with multiple sclerosis, and 100 healthy controls recruited as a comparator group. The inclusion of healthy participants will contribute to comparisons with the case population. This study will last about 5 years.

Enrollment Information:  This study is open for enrollment. Please contact Ashley Fair.

International Multiple Sclerosis Microbiome Study

Our neuroimmunology team is participating in the International Multiple Sclerosis Microbiome Study (iMSMS). The cause of Multiple Sclerosis is yet unclear, but it is evident that it includes a combination of genetic factors and environmental factors. One standout environmental factor is the microbiome, or the genetic material of bacteria inside the GI tract. This study aims to understand how the environment influences MS risk, by studying microbiome of MS patients in comparison to their healthy cohabitants.

Enrollment Information: We are collecting stool and blood samples from MS patients and a genetically unrelated healthy counterpart living in the same household (i.e a spouse, roommate or adoptive parent). This study is open for enrollment. Please contact Tamara Shabi.

NACPMS

UCSD has teamed up with UCSF to determine the safety, tolerability, and effectiveness of N-Acetyl Cysteine (NAC) on neurological oxidative stress in patients with primary and secondary progressive Multiple Sclerosis (PPMS/SPMS). Those participating in this study can expect to take either NAC or a placebo for 15 months, monthly check in calls, blood-draws, questionnaires, MRI, and functional testing/assessments.

Enrollment Information: This study is open for enrollment. Please contact act Ashley Fair.

MSight

The Neuroimmunology department has been working with the engineering department at UCSD to find an accurate way to measure neuronal dysfunction in those with Multiple Sclerosis and traumatic brain injury. This is accomplished by finding those with specific symptomology to undergo a virtual reality eye tracking measurement which is intended to measure eye movement and an EEG/EOG to measure the efferent neuronal firing pattern.

BioAging Study

Our BioAging study investigates the association of biological aging of senescent cells and aging in multiple sclerosis patients. This study aims to identify potential pathways through which relapsing forms of MS advance into progressive forms of MS.

Enrollment Information: This study consists of a single blood-draw, and is now actively recruiting both MS and healthy control participants.

TRAC MS Study

TRAC MS, or The Repository of Advanced Clinical Metrics in MS, is a research study that aims to find out more about the development, diagnosis, treatment and long-term outcomes of MS and related diseases. This database study will help us see how MS impacts our patient population as a whole, which may lead to a better understanding of MS disease course and treatment.

Enrollment Information: This study is actively recruiting patients with MS or a related disease.

TREAT-MS Study

We are working with Johns Hopkins University and the Patient Centered Outcomes Research Institute (PCORI) to help identify the most efficacious treatment strategies for relapsing-remitting Multiple Sclerosis. In the last few decades, we have developed new, stronger and more aggressive therapies to prevent relapse and disability in MS. Since the advent of new therapies, it is important to investigate if new patients benefit from the older, milder therapies or if the risk of relapse and disability are best addressed with stonger therapies early in the disease course.

Enrollment Information: The TREAT-MS study follows volunteer patients for the first few years of their MS therapy, and tracks their disease progression, disability risk and satisfaction.

Perseus Study 

This is a Phase 3, randomized, double-blind, 2-arm, placebo-controlled, parallel-group, multicenter, event-driven (6-month CDP) trial in 990 participants with PPMS (primary progressive MS) with a variable treatment duration ranging from approximately 24 to 48 months to demonstrate the efficacy and safety of SAR442168 (tolebrutinib) adminstered 60mg daily compared to placebo.

Enrollment Information:  This study is open for enrollment. Please contact Gisselle Paez.

FREVIVA Study 

This is a parallel group, Phase 3 study with 2-arms for treatment that are blinded/masked for participants, the Investigator, any Investigator site staff, and the Sponsor. The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy in delaying the disability progression and the safety of up to approximately 51 months administration of frexalimab IV every 4 weeks (q4w) compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. The primary objective of this study is to assess the efficacy of frexalimab compared to placebo in delaying disability progression in nrSPMS. The secondary objectives of this study are to assess the efficacy of frexalimab compared to placebo on clinical endpoints, MRI lesions, cognitive performance, physical function, and quality of life, evaluate safety and tolerability of frexalimab, evaluate pharmacodynamics of frexalimab in participants with nrSPMS, evaluate pharmacokinetics of frexalimab in nrSPMS.

Enrollment Information:  This study is open for enrollment. Please contact Gisselle Paez.

Closed Studies

MOVING MS Study

Our research group has collaborated with Octave Bioscience Inc. in order to implement their Octave Care Platform in a research trial. The MOVING MS study investigates the impact of a Care Platform, complete with medication and symptom tracking, as well as access to a Care Partner, on patient satisfaction and healthcare utilization. Participation in this trial includes access to the Octave Care mobile app, as well as the completion of blood-draws and questionnaires over a 12-month period.

Enrollment Information: Enrollment for this study has closed.

NOVA Study

The NOVA study is aimed at assessing the efficacy of Natalizumab (Tysabri) in Multiple Sclerosis patients at an interval of 6 weeks between doses, in contrast with the traditional 4 week interval. The study aims to test if the risk of developing Progressive Multifocal Leukoencephalopathy, a fatal progressive neurological disease caused by the John Cunningham Virus, is decreased by extending the interval of dosage. We will be following patients for 72 months, tracking their health and disease outcomes.

Enrollment Information: Enrollment for this study has closed.

ATARA Study

This is a multi-center Phase 1/2 clinical trial in patients with progressive forms of Multiple Sclerosis (MS). This trial aims to look at the effects of using ATA188 in these progressive patients, and to understand if the administration of this drug slows down disease progression and disability accumulation. This is a randomized study where progressive MS patients will be given ATA188, and their clinical outcomes documented. This study will last for 5 years. All randomized patients will be given both a placebo and ATA188 throughout the course of the study. The overall aim of this study is to evaluate the effect of ATA188 treatment on clinical disability, as assessed by sustained Expanded Disability Status Scale (EDSS) improvement at 12 months, and to characterize the safety and tolerability of adoptive transfer of ATA188 as a monotherapy, in subjects with progressive forms of MS.

Enrollment Information: Enrollment for this study has closed.