A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis
Recruiting
The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of... Read More
Gender:
All
Ages:
Between 18 years and 55 years
Trial Updated:
12/07/2023
Locations: Neurology Clinic, PC, Cordova, Tennessee
Conditions: Relapsing Forms of Multiple Sclerosis
Study to Evaluate the Safety and Efficacy of PIPE-307 in Subjects With Relapsing-Remitting Multiple Sclerosis
Recruiting
This is a randomized, double-blind study of PIPE-307 or placebo in subjects with relapsing-remitting multiple sclerosis. Subjects will be randomized into 1 of 3 separate cohorts (1:1:1 randomization ratio, PIPE-307 Dose A:PIPE-307 Dose B: Placebo) for a total duration of approximately 30 weeks.
Gender:
All
Ages:
Between 18 years and 50 years
Trial Updated:
12/05/2023
Locations: Sibyl Wray Neurology PC, Knoxville, Tennessee
Conditions: Relapsing Remitting Multiple Sclerosis
A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Recruiting
A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
Gender:
All
Ages:
Between 18 years and 55 years
Trial Updated:
11/30/2023
Locations: Neurology Clinic PC, Cordova, Tennessee +1 locations
Conditions: Relapsing Multiple Sclerosis
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
Recruiting
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with PPMS, in comparison to the approved 600 mg dose of ocrelizumab.
Gender:
All
Ages:
Between 18 years and 55 years
Trial Updated:
11/28/2023
Locations: Neurology Clinic PC, Cordova, Tennessee +3 locations
Conditions: Multiple Sclerosis
Study to Evaluate the Maintenance of Efficacy When Transitioning From Anti-CD20 Therapy to Ublituximab (ENHANCE)
Recruiting
The primary purpose of this phase 3b study is to assess the maintenance of efficacy after transition from current anti-CD20 therapy to ublituximab, as measured by T1 Gadolinium (Gd)-enhancing lesions.
Gender:
All
Ages:
Between 18 years and 65 years
Trial Updated:
10/20/2023
Locations: TG Therapeutics Investigational Trial Site, Knoxville, Tennessee
Conditions: Relapsing Multiple Sclerosis
Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial
Recruiting
FDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Ear... Read More
Gender:
All
Ages:
Between 18 years and 60 years
Trial Updated:
10/09/2023
Locations: Vanderbilt Comprehensive MS Center, Nashville, Tennessee
Conditions: Multiple Sclerosis, Relapsing-Remitting
A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation
Recruiting
This study will evaluate if relapsing-remitting MS patients that have not had a relapse in the past year would benefit from a switch to ofatumumab versus staying on their continued current therapy. This study will also look at whether an elevated serum neurofilament light (NfL) level predicts enhanced benefit from a switch to ofatumumab.
Gender:
All
Ages:
Between 18 years and 50 years
Trial Updated:
10/09/2023
Locations: Novartis Investigative Site, Knoxville, Tennessee
Conditions: Relapsing-Remitting Multiple Sclerosis
Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS
Recruiting
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).
Gender:
All
Ages:
Between 18 years and 100 years
Trial Updated:
09/29/2023
Locations: Novartis Investigative Site, Cordova, Tennessee +3 locations
Conditions: Relapsing Multiple Sclerosis
Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)
Recruiting
Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relations... Read More
Gender:
All
Ages:
Between 18 years and 55 years
Trial Updated:
08/15/2023
Locations: Advanced Neuroscience Center-Site Number:8400035, Franklin, Tennessee
Conditions: Primary Progressive Multiple Sclerosis
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Recruiting
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis
Gender:
All
Ages:
Between 18 years and 55 years
Trial Updated:
07/13/2023
Locations: Novartis Investigative Site, Knoxville, Tennessee
Conditions: Relapsing Multiple Sclerosis
Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.
Recruiting
This study will evaluate the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study will also assess changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if... Read More
Gender:
All
Ages:
Between 18 years and 35 years
Trial Updated:
07/11/2023
Locations: Novartis Investigative Site, Knoxville, Tennessee
Conditions: Relapse Remitting Multiple Sclerosis
Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy
Recruiting
This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta's or receiving no disease modifying therapies (DMTs). The data of this study will support the labels for ozanimod in multiple sclerosis (MS) because the effect of ozanimod on the vaccination response of MS participants is of interest to participants and prescribers.
Gender:
All
Ages:
Between 18 years and 65 years
Trial Updated:
03/10/2023
Locations: Hope Neurology MS Center, Knoxville, Tennessee
Conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting