clinical trials

I wrote in the summer about changing the disease-modifying therapy (DMT) for my multiple sclerosis (MS). I’ve familiarized myself with the available DMTs, and I plan to ask my neurologist for her recommendation next week and then make a decision. As I’ve researched my options, I’ve become interested…

Gadoquatrane, a contrast agent Bayer is developing for MRI scans, showed similar safety and pharmacokinetic (PK) profiles — meaning how a drug moves into, through, and out of the body — in both children and adults. That’s according to data from the Phase 3 QUANTI Pediatric study (NCT05915026),…

Lynk Pharmaceuticals has received the green light from the U.S. Food and Drug Administration (FDA) to begin clinical trials of its investigational oral therapy LNK01006, which is being developed for multiple sclerosis (MS) and other neuroinflammatory diseases. “We look forward to advancing this promising molecule into human clinical…

As a law student in the Czech Republic, Jana Hlavacova specialized in international law and international relations, but a multiple sclerosis (MS) diagnosis led her to shift her professional focus. Applying her legal expertise to her work at the Czechia Ministry of Health, she now helps shape healthcare policy…

An artificial intelligence (AI)-based tool called Muse aims to accelerate drug development by optimizing clinical trial patient recruitment. The tool, designed as part of a collaboration among Formation Bio, OpenAI, and Sanofi, is designed to be implemented across a range of areas. Sanofi will first put it…

An independent data monitoring committee has recommended that the twin ENSURE Phase 3 trials testing vidofludimus calcium in people with relapsing forms of multiple sclerosis (MS) continue as planned without adjustments. The opinion that the trials are worth continuing was based on a review of interim, unblinded trial…

Sudo Biosciences has secured an additional $30 million in funding to support the development of two TYK2 inhibitor therapies for multiple sclerosis (MS) and other neurological and skin conditions — and now is aiming to launch clinical trials later this year. With a second close of its Series…

Few multiple sclerosis (MS) clinical trials have used a so-called pragmatic design, which evaluates the effectiveness of interventions in real-life routine practice, a study has found. Because such trials are better able to emulate conditions in real-world clinical practice and provide solid and more actionable evidence to inform treatment…

EBV-001, a vaccine candidate being developed by EBViously to target the Epstein-Barr virus (EBV), triggered the production of potent antibodies against the virus in mice, and blood samples from these animals prevented EBV infection in lab-grown human cells. That’s according to new data presented by the company, which is…

Treatment with the cannabis oral spray nabiximols helped to relieve spasticity — increased muscle stiffness and spasms common in people with multiple sclerosis (MS) — among participants in two MS clinical trials, according to the results of a new analysis. “In this analysis, nabiximols was shown to significantly…

Clinical trials testing rehabilitation strategies for people with multiple sclerosis (MS) include a disproportionate number of white participants and have generally paid little attention to how race and ethnicity may influence outcomes. Further, few efforts have been undertaken to make MS trials more racially and ethnically diverse. A team…

Researchers have created a computer program that can simulate clinical trial responses for relapsing-remitting multiple sclerosis (RRMS), which may improve clinical trial design for novel disease-modifying therapies. The tool, called MS TreatSim, was described in the study, “In silico clinical trials for relapsing-remitting multiple sclerosis…

Measuring disability progression every time it occurs, rather than just tracking whether it occurs, could improve the statistical power of clinical trials in multiple sclerosis (MS), particularly for progressive forms of the disease. That’s according to scientists at Roche and several academic institutions who published their findings in…

A new machine learning tool could help make clinical trials for progressive forms of multiple sclerosis (MS) more efficient and effective, a study suggests. Its scientists propose that the tool, when used in initial patient studies, works to more rapidly move a potential progressive MS treatment into pivotal Phase…

In this installment of our “Expert Voices” series, Multiple Sclerosis News Today asked Tanuja Chitnis, MD, to answer some of your questions about pediatric multiple sclerosis (MS). Chitnis is a board-certified neurologist specializing in multiple sclerosis-related neuroimmunological disorders. Chitnis’s interest in children with MS led her to create…

In December 2019, I was stopped in my tracks, or rather wheels, as I was about to have my third infusion of Ocrevus (ocrelizumab), the multiple sclerosis disease-modifying therapy (DMT) that I’d been taking every six months for the past year. My neurologist had decided just a few…

An international team of scientists is calling for more rigorous studies to test whether exercise can help protect the nervous system from damage in people with multiple sclerosis (MS). The scientists argue clinical trials that have evaluated exercise in MS have marked flaws in their design, making…

EMBOLD Study of ATA188 in Progressive MS Is Given Go-ahead Is this another small step toward an MS cure? AT188 is an experimental therapy designed to kill cells infected with the Epstein-Barr virus (EBV). As you probably know, researchers have found a lot of evidence that EBV is connected…

The safety and efficacy of the approved multiple sclerosis (MS) therapy Mavenclad (cladribine) in a real-world group of patients were similar to what had been demonstrated in clinical trials, a new study reports. Among 243 people with relapsing-remitting multiple sclerosis (RRMS), more than 60% showed no…

Autologous hematopoietic stem cell transplant (aHSCT) has shown some promise as a treatment option for highly active relapsing-remitting multiple sclerosis (RRMS), but more clinical evidence is needed to support its use, a team of researchers in the U.K. suggest. “Uncertainty remains as to how aHSCT compares with current…

The National Institutes of Health (NIH) is joining the search for a vaccine to attack the Epstein-Barr virus (EBV). This is a big deal for people with multiple sclerosis, because carrying the virus is thought to play a significant role in the development of MS. In fact,…

I’m marking a big anniversary this month. It’s been four years since I finished the second round of treatment with Lemtrada (alemtuzumab), my final disease-modifying therapy (DMT). That means that, after about 60 monthly blood draws, I’m finished being stuck. Lemtrada is usually a two-phase series of injections, with…

Treatment with Kesimpta (ofatumumab) for more than three years revealed no new or unexpected safety findings, and continued to slow disability progression and prevent the development of new brain lesions in people with relapsing multiple sclerosis (MS), according to new clinical trial data. Information from another trial also…

The National MS Society, together with a number of its corporate healthcare partners, want to help correct the lack of diversity in clinical trials as part of an effort toward resolving healthcare inequities in the MS community. To address these disparities, the National MS Society’s Corporate Healthcare Roundtable, a…

#ACTRIMS2022 – Cognitive Training Paired With tDCS Aids Patients A treatment to clear “cog fog” would be welcomed by many people with MS. Over 75% of us are troubled by cognitive problems. In this study, adding painless transcranial direct current stimulation to standard cognitive training improved results when compared…

VISIONARY-MS, a Phase 2 clinical trial evaluating the safety and effectiveness of CNM-Au8 in people with relapsing multiple sclerosis (MS) with disease-related visual impairment, will conclude early due to COVID-19 pandemic-related challenges. The release of trial data is expected in the second half of this year, according to…

Other autoimmune conditions, particularly those characterized by the presence of anti-TPO antibodies, should not preclude patients with multiple sclerosis (MS) from receiving treatment with Lemtrada (alemtuzumab), according to an analysis of pooled data from clinical trials and post-market data. The study, “Autoimmunity and long-term safety and efficacy…

Immunic Therapeutics has enrolled the first participant in its Phase 3 ENSURE clinical trial program, which is testing the company’s investigational treatment IMU-838 (vidofludimus calcium) in people with relapsing-remitting multiple sclerosis (RRMS). “Enrollment of the first patient in ENSURE … marks an important inflection point for Immunic as we…

ImStem Biotechnology announced that the first patient in its Phase 1 clinical trial for IMS001, an investigational treatment for multiple sclerosis (MS), has been dosed at the Shepherd Center in Atlanta. The trial (NCT04956744) is recruiting participants with an MS diagnosis ages 18 to 65. More information…

Sanofi Genzyme has extended its collaboration with Koneksa to bring digital measures into its Phase 3 trials of tolebrutinib, an investigational therapy for relapsing and progressive forms of multiple sclerosis (MS). Through this joint effort, Koneksa’s digital biomarkers were applied to clinical trials of Parkinson’s…