clinical trials

High blood levels of the nerve damage biomarker neurofilament light chain (NfL) significantly increased the risk of people with clinically isolated syndrome (CIS) converting to definite multiple sclerosis (MS), according to an analysis of clinical trial data. CIS patients with higher NfL levels also made the transition earlier…

A clinical trial testing SpineX‘s Scone neuromodulation device for treating a neurogenic, or overactive, bladder, a common symptom of multiple sclerosis (MS), has finished enrolling patients. Called CONTINENCE (NCT05301335), the study enrolled adults with overactive bladder due to MS, stroke, or spinal cord injury at…

Scientists have created an assay that can measure immune cells’ inflammatory attack against the Epstein-Barr virus (EBV), a known risk factor for multiple sclerosis (MS). Researchers found preliminary evidence that some MS treatments, but not others, may alter the immune system’s response to EBV. The scientists said the…

Kyverna Therapeutics‘ cell-based therapy KYV-101 had an acceptable safety profile and promising treatment effects when given to two people with hard-to-treat progressive multiple sclerosis (MS), according to a case study. “We are very pleased about offering this potentially paradigm-shifting treatment opportunity to patients that have exhausted other medical…

FSD Pharma has entered an agreement to launch a Phase 1 clinical trial that will test multiple ascending doses of Lucid-21-302 — an oral treatment candidate commonly known as Lucid-MS, for all types of multiple sclerosis (MS) — in healthy volunteers. The company’s subsidiary Huge Biopharma Australia established…

People with multiple sclerosis (MS) have a twofold higher risk of seizures compared with the general population, according to pooled data from clinical trials. Among MS patients, treatment with sphingosine-1-phosphate receptor (S1PR) modulators, a class of MS disease-modifying therapies (DMTs) that includes the oral medications Gilenya (fingolimod),…

The Polish biotechnology company PolTREG plans to launch Phase 2 trials testing its Tregs therapy — the T-cell-based treatment PTG-007 — in people with multiple sclerosis (MS) in Poland later this year. The biotech company has earned a Current Good Manufacturing Practice (CGMP) certification for its new manufacturing…

Researchers at Stanford University have partnered with Kyverna Therapeutics to conduct an investigator-initiated clinical trial of the company’s cell-based therapy, KYV-101, in people with progressive forms of multiple sclerosis (MS) without relapses. The open-label Phase 1 trial (NCT06138132) will take place at the Stanford Multiple Sclerosis…

Nearly half of all multiple sclerosis (MS) patients who participated in clinical trials — including global, pivotal studies — had one or more comorbidities, or coexisting conditions, the most common being depression and high blood pressure, a meta-analysis study found. While the rate of patients with comorbidities “may be…

Convelo Therapeutics is developing two experimental oral treatments to promote myelin repair in multiple sclerosis (MS) and both have shown promise in preclinical models. The company is in the final stages of safety studies in large animals. Once those studies are done, it plans to start studies that…

Nearly one year of treatment with tolebrutinib, an oral small molecule being developed by Sanofi, failed to eliminate iron rim lesions in adults with multiple sclerosis (MS), according to data from a small Phase 2 clinical trial. Researchers are continuing to examine study results to determine…

The experimental BTK inhibitor evobrutinib was no better than Aubagio (teriflunomide) at preventing relapses, reducing brain lesions, or slowing disability progression in people with relapsing forms of multiple sclerosis (MS), according to data from two Phase 3 trials. Both medications had generally similar safety profiles, although increases…

Repeated treatment with the mesenchymal stem cell therapy NG-01 led to gains in mobility and cognition, along with patient-reported quality of life, for most people with progressive multiple sclerosis (MS) in an extension study. Markers of nerve damage were also reduced, indicating significant nerve-protecting effects. Dimitrios Karussis, MD,…

About two-thirds of people with relapsing forms of multiple sclerosis (MS) remained completely free from relapses over six years of treatment with Zeposia (ozanimod) in the DAYBREAK clinical trial. Most also saw no sustained disability progression during that period and the mean number of new or enlarging lesions…

Coupling a noninvasive brain stimulation procedure with an intensive rehabilitation program significantly improved motor function and balance in adults with relapsing-remitting multiple sclerosis (RRMS), a randomized clinical trial finds. High-frequency repetitive transcranial magnetic stimulation (rTMS) is a noninvasive treatment approach that delivers pulses of magnetic fields to modulate nerve…

Treatment options for progressive types of multiple sclerosis (MS) have expanded dramatically over the past decade, and several promising experimental therapies are in late stages of clinical development, a new review paper highlights. The study, “Clinical trials for progressive multiple sclerosis: progress, new lessons learned, and…

Bolstered by Phase 2 trial data showing that frexalimab safely reduces the number of brain lesions in people with relapsing forms of multiple sclerosis (MS), developer Sanofi has launched a pair of Phase 3 studies that will test the investigational therapy in relapsing and progressive MS. One of…

Taking caffeine tablets — the equivalent to about two cups of coffee a day — may help people with multiple sclerosis (MS) keep their balance and move more easily, which could aid their quality of life, a small study suggests. While the tablets may…

An intermittent fasting (IF) diet may lead to immune and metabolic alterations that ease multiple sclerosis (MS) symptoms and improve quality of life, a recent review of published studies suggests. While evidence from these few small clinical trials indicates an IF diet…

A small clinical trial in Texas is testing whether a noninvasive magnetic brain stimulation procedure can ease the symptoms of overactive bladder in adults with multiple sclerosis (MS). The randomized Phase 2 study (NCT06072703) is ongoing at Houston Methodist Hospital, and is recruiting about 29 women with stable…

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…

Use of oral ibudilast — being explored as a treatment for progressive forms of multiple sclerosis (MS) — was found to significantly slow the growth of chronic active lesions in the brains of patients with the neurodegenerative disease, according to MRI data from the SPRINT-MS study. Such lesions…

The U.S. Food and Drug Administration (FDA) has granted fast track status to KYV-101, Kyverna Therapeutics’ cell-based therapy candidate for people with progressive forms of multiple sclerosis (MS) that are treatment-resistant. The FDA designation is intended to accelerate the development of therapies that aim to address unmet medical…

Mitochon Pharmaceuticals is launching a pilot clinical trial to evaluate MP101, its treatment candidate for improving mitochondrial function, in people with multiple sclerosis (MS) and other neurodegenerative diseases. The announcement follows the trial’s clearance by the European Medicines Agency (EMA), which enables Mitochon to begin enrolling patients with…

Myrobalan Therapeutics has secured $24 million in series A financing to support the development of oral medications for multiple sclerosis (MS) and other diseases of the central nervous system (CNS), which comprises the brain and spinal cord. The company’s pipeline currently includes three candidate therapies…

Monte Rosa Therapeutics is planning to initiate a Phase 1 clinical trial to test MRT-6160, its investigational therapy for multiple sclerosis (MS) and other autoimmune diseases, by mid-2024. The trial will follow the submission of an investigational new drug (IND) application, a formal request to U.S. regulatory authorities…

Daily treatment with CNM-Au8 led to sustained improvements in vision and cognition for people with relapsing-remitting multiple sclerosis (RRMS), according to nearly three years of follow-up in the VISIONARY-MS trial and its open-label extension (OLE). Developer Clene Nanomedicine plans to present full trial results at the upcoming ACTRIMS…

Treatment with Ocrevus (ocrelizumab) may stabilize disability progression in people with multiple sclerosis (MS) who have severe walking impairments — a patient group excluded from clinical trials supporting the therapy’s 2017 approval — a real-world analysis suggests. However, about half of those receiving Ocrevus in this study discontinued…

The U.S. Food and Drug Administration (FDA) has cleared a Phase 2 clinical trial to test Kyverna Therapeutics‘ cell-based therapy candidate KYV-101 in people with treatment-resistant progressive multiple sclerosis (MS). Called KYSA-7 (NCT06138132), the open-label trial will enroll an estimated 12 patients with either primary progressive…