Clinical Research Directory

Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis

The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS. The main questions the trial aims to answer are the following: * Is TRX319 safe when administered to patients with progressive forms of MS? * At what dose does TRX319 work the best to treat participants with primary and or secondary progressive MS? * Is pre-conditioning (with Bendamustine) needed to allow TRX319 to better treat participants with primary and/or secondary progressive MS? Participants will be asked to be on study for up 1 year and may receive up to 3 total administrations of TRX319. While on study, participants will have blood tests and other assessments (MRI scans and lumbar punctures) done to understand the safety of TRX319 and how it may benefit their multiple sclerosis.

Home Based Functional Balance Intervention for Multiple Sclerosis

The study involves a two-arm, Phase 1, randomized controlled clinical trial designed to establish the feasibility and effects of a Functional Balance Intervention (FBI) on physical and cognitive function, as well as measures of daily living among persons with multiple sclerosis (PwMS). Combined Specific Aims: Aim 1: Examine the effect of the FBI (Intervention Group) on physical function in PwMS compared to a stretching program (Control Group). Hypothesis 1: After four months of training, the FBI group will show significantly greater improvements in physical function compared to the stretching group. Aim 2: Examine the effect of the multicomponent FBI on cognitive function in PwMS compared to the stretching program. Hypothesis 2: After four months of training, the FBI group will show significantly greater improvements in cognitive function compared to the stretching group. Aim 3: Examine the effects of the multicomponent FBI compared to the Control Group among PwMS on measures of daily living (dual-task performance, balance confidence, community mobility, and quality of life). Hypothesis 3: After four months of training, the FBI group will show significantly greater improvements in measures of daily living compared to the stretching group. All assessment sessions will be conducted virtually via Zoom. All measures collected during the initial screening, pre-training assessment, training progression, and mid- and post-training assessment sessions will be administered either via Zoom with a Helper Buddy present or through survey links sent to participants via the UIC REDCap system. The training sessions will be performed independently by the participants in the presence of a Helper Buddy. The investigators will recruit 75 people with multiple sclerosis (PwMS) for this study. Eligible participants will be randomized to either the FBI (Intervention) or stretching (Control) group, followed by an onboarding session with a designated Helper Buddy. Training will occur twice weekly for four months. Based on the anticipated attrition rate, the investigators aim for 40 PwMS to complete the post-training assessments and finish the study.

A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis

Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.

"Selfie" Videos: A Novel, Patient-centered, Comprehensive Approach to Measuring Function in MS

The goal of this observational study is to validate a novel, cost-effective method for real-world assessment using patient-acquired "selfie" videos in people with multiple sclerosis. The investigators aim to prove the feasibility and validity of monitoring walking changes remotely through a truly patient-centered, low-burden, low-cost approach. The main question this study aims to answer is: do remotely collected walking and speech videos from a mobile phone match the information investigators can gather from an in person visit? Participants will collect 5 "selfie" videos at baseline, 3 months, 6 months and 12 months (about 15 minutes every 3 months). They will also come in person at baseline, 6 months, and 12 months for in person data collection (about 1 hour per in person visit).

A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS

The study is an investigator-run, study following participants for 2 years with twice-daily remibrutinib. MRI is the main endpoint. Safety, tolerability, and efficacy are secondary endpoints. Approximately 20 participants with relapsing or progressive forms of MS will be recruited.