clinical trials

The investigational anti-CD20 antibody ublituximab effectively depletes B-cells in people with relapsing forms of multiple sclerosis (MS), reducing the appearance of brain lesions and the risk of relapses, a study into clinical trial results suggests. Findings further suggest that the…

The investigational, oral BTK inhibitor SAR442168 can limit the number of new inflammatory brain lesions in people with relapsing forms of multiple sclerosis (MS), results from a Phase 2b clinical trial show. “The results of this study give hope that SAR442168 may become an important…

People with secondary progressive multiple sclerosis (SPMS) who began treatment with Mayzent early and continued its use for years are less likely to experience disability progression than those starting the medication later in their disease course, five-year data from the EXPAND study suggest. Data from this same Phase 3…

With the development of a cell line that produces significant amounts of Immutep‘s treatment candidate, IMP761, the company is preparing to advance its antibody into clinical testing for autoimmune conditions, including multiple sclerosis (MS). Immutep also reports that is adapting its manufacturing operations to comply with…

Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…

The MIST Phase 2 clinical trial, supporting the potential of hematopoietic (blood cell-producing) stem cell transplant (HSCT) to significantly slow disability progression in highly active relapsing-remitting multiple sclerosis (RRMS) patients, has received a Distinguished Clinical Research Achievement Award from the Clinical Research (CR) Forum. Five years after the transplant, most…

New Database to Compile COVID-19 Data About People with MS and Related Diseases There are databases in the U.K. and other parts of Europe for tracking people with MS who have tested positive for COVID-19. This one is aimed at people in North America. This site will join the…

In response to the COVID-19 pandemic, Atara Biotherapeutics has temporarily paused patient enrollment in the second and randomized part of its ongoing Phase 1 clinical trial investigating ATA188 in people with progressive forms of multiple sclerosis (MS). People treated in the first, open-label part of this trial, however,…

Multiple sclerosis (MS) patients have lower than usual levels of molecules called bile acids circulating in their blood, a  study found. These molecules, produced in the liver to aid fat absorption in the gut, also appear to block inflammation and nerve cell damage in the brain. Oral treatment with …

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold and cleared the investigational new drug (IND) application to assess IMS001 in the treatment of multiple sclerosis (MS), ImStem Biotechnology announced. The company plans to start a Phase 1 study in the U.S. this…

A planned Phase 2 clinical trial of a potential treatment for progressive multiple sclerosis has been postponed to keep hospital resources open to treat people with COVID-19 during the ongoing global outbreak, and to reduce the risk of exposure to MS patients, GeNeuro, the investigate therapy’s developer, announced. The…

Oral treatment with Gilenya (fingolimod) is more effective than Avonex (interferon beta-1a) for controlling brain lesion activity and brain volume loss in children with pediatric-onset multiple sclerosis (POMS), two-year results of the PARADIGMS study show. That means Gilenya provides an effective treatment option for…

Second Phase 3 Trial of MedDay’s MD1003 for Progressive MS Fails to Meet Goals This is disappointing news about what scientists had hoped would be another oral disease-modifying therapy for multiple sclerosis. It’s doubly disappointing because MD1003 is aimed at progressive forms of MS and demyelination, and we need…

MedDay Pharmaceuticals‘ MD1003 did not ease functional disability or its progression in patients with non-active progressive multiple sclerosis, Phase 3 clinical trial data shows. The SPI2 Phase 3 study (NCT02936037) sought to confirm the positive results of a first Phase 3 trial called MS-SPI…

The Partners Multiple Sclerosis Center at Brigham and Women’s Hospital has joined BrainStorm Cell Therapeutics in a Phase 2 trial exploring the safety and efficacy of NurOwn in the treatment of progressive multiple sclerosis (MS). This is the fifth and final clinical site participating in…

Treatment for two months with N-acetylcysteine, or NAC — a natural molecule that enhances the levels of antioxidants — significantly improved metabolic activity in certain brain regions among people with multiple sclerosis (MS), a small clinical study reports. This increase in metabolic activity was accompanied by improvements…

Emerald Health Pharmaceuticals’ investigational cannabidiol-derived EHP-101 continues to show potential to ease inflammation and myelin loss (demyelination) — a hallmark of multiple sclerosis (MS) — according to data from healthy volunteers and a mouse model of MS. The data support the advance of EHP-101’s clinical development into…

Acthar Gel (repository corticotropin injection) leads to significant improvements after two months of use in people with multiple sclerosis (MS) still having acute relapses despite treatment, and who failed to respond to other high-dose corticosteroids, topline data from an observational study show. The gel’s developer, Mallinckrodt Pharmaceuticals, also…

AB Science‘s masitinib significantly slowed disability progression in people with primary progressive multiple sclerosis (PPMS) and non-active secondary progressive MS (SPMS) at a lower dose of 4.5 mg/kg a day, top-line results from a Phase 2b/3 clinical trial show. Masitinib, formerly known as AB1010, is an oral…

A bone marrow transplant can remove the majority of overactive immune T cells from the central nervous system (CNS) in patients with active relapsing-remitting multiple sclerosis (RRMS), allowing the body to replace them with healthy ones, a study has found. This opens up new treatment avenues to…

The new year brings many changes, including the last year of my clinical trial. When I think about the past seven years, I am thankful for the opportunity to join the trial when I did and receive personal care that made fighting MS easier. It may sound crazy, but…

Clene Nanomedicine‘s remyelination therapy candidate, CNM-Au8, showed a “robust” ability to stimulate the production of new myelin and increase the number of myelin-wrapped nerve fibers in the brain and spinal cord of animals in models of demyelinating disease, allowing mice to recover motor skills, a study reports.

Editor’s note: “Need to Know” is a series inspired by common forum questions and comments from readers. Have a comment or question about MS? Visit our forum. This week’s question is inspired by “Newly Diagnosed MS Patients Show Changes in Gut Microbiome, Study Says,” from Dec. 3, 2019.

Myelin is the protective sheath that covers nerve fibers and is damaged in those with multiple sclerosis. Quantifying the degenerative process of myelin would lend perspective to how much and where a patient is progressing. Currently, MRIs are used for diagnostic purposes, but the nuances of progression remain difficult…

Scientists discovered new interaction between immune cells from the central nervous system (CNS) — consisting of the brain and spinal cord — and immune cells from the blood that may lead to new treatments for multiple sclerosis (MS) and other neurological diseases.

The U.S. Food and Drug Administration (FDA) has agreed to allow Myeliviz, an imaging agent of myelin — the protective layer that covers nerve fibers and is damaged in multiple sclerosis (MS) — to be evaluated in a clinical trial with healthy volunteers. Myeliviz, created by Case Western Reserve University researchers, has the potential…

MedRhythms is planning to soon open a pilot clinical trial to assess the safety and efficacy of its MR-004, its investigational product that uses rhythmic sounds to improve walking abilities in people with multiple sclerosis (MS), the company announced. The randomized and controlled trial, fully support by a grant…

People with multiple sclerosis have been waiting for this: A full-scale clinical trial testing the effectiveness of stem cell transplantation as an MS treatment. The trial is being conducted by the U.S. National Institutes of Health, and it’s enrolling people with MS at several centers in the United States and…

New Trial Compares Stem Cell Treatment to Available Therapies for Severe Relapsing MS This is a biggie. The U.S. National Institutes of Health is conducting a head to head study comparing autologous hematopoietic stem cell transplantation (AHSCT) to the high-efficacy, disease-modifying therapies currently being used: Tysabri, Lemtrada, Ocrevus, and…

The first participant has been dosed in the Phase 2 REPAIR-MS clinical trial examining the effects of CNM-Au8, Clene Nanomedicine‘s investigational remyelinating therapy, on brain metabolism in people with multiple sclerosis (MS), the company announced. In MS, the immune system attacks myelin, the protective sheath that surrounds…