clinical trials

Tevogen Bio has announced plans to develop T-cell therapies targeting the Epstein-Barr virus (EBV), a herpes virus known to be a major environmental risk factor for multiple sclerosis (MS). The decision comes on the heels of positive safety data from a proof-of-concept Phase 1 Tevogen trial that…

Daily treatment with an oral antidepressant called bupropion — marketed as Wellbutrin and Zyban, among others — significantly improved some aspects of sexual function in women with multiple sclerosis (MS), according to the results of a randomized trial in Iran. “The results of our study showed bupropion can…

Foralumab nasal spray, an experimental therapy by Tiziana Life Sciences that’s being tested for multiple sclerosis and other autoimmune and nervous system diseases, was found to be safe and able to modulate the immune system in healthy volunteers, a study has found. Researchers failed to detect antibodies…

Dosing of NVG-291, NervGen Pharma’s investigational therapy for multiple sclerosis (MS) and other nervous system diseases, was completed in the third and final group of healthy postmenopausal women in a Phase 1 clinical trial. “Completing the dosing of the final [group] of postmenopausal females in the MAD [multiple…

Welcome to “MS News Notes,” where I comment on multiple sclerosis (MS) news stories that caught my eye last week. Here’s a look at what’s happening: Could a nasal spray join the MS treatment arsenal? Shots, pills, and infusions are approved in the U.S. as disease-modifying therapies for MS,…

Tiziana Life Sciences plans to request a meeting with the U.S. Food and Drug Administration (FDA) later this year to discuss the upcoming Phase 2 clinical trial of foralumab nasal spray in people with nonactive secondary progressive multiple sclerosis (SPMS). FDA feedback on the design of the…

An upcoming observational clinical trial will assess how adherence to treatment with the portable neuromodulation stimulator (PoNS) device, used in the clinic and later at home, improves gait in people with multiple sclerosis (MS). Sponsored by Helius Medical Technologies, the device’s developer, the open-label Therapeutic…

Long-term use of the investigational BTK inhibitor evobrutinib among people with relapsing forms of multiple sclerosis (MS) continues to maintain MS relapse rates, and keep MRI lesion activity low. That’s according to up to 3.5 years of data from a Phase 2 trial (NCT02975349) and its open-label…

Treatment with Tecfidera (dimethyl fumarate) significantly reduces the risk of experiencing the first multiple sclerosis (MS) symptoms in adults with radiologically isolated syndrome (RIS), according to data from a Phase 4 clinical trial. RIS is a condition in which patients have MS-like lesions on MRI scans, but…

Long-term treatment with Gilenya (fingolimod) continues to be safe and lower the rate of relapses in children and adolescents with multiple sclerosis (MS) more than Avonex (interferon beta-1a) does. That’s according to up to six years of data from the ongoing PARADIGMS Phase 3 trial (NCT01892722), wherein…

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…

Four weeks of treatment with nabiximols — an oral spray containing compounds found in the cannabis plant — significantly reduced spasticity and generally improved arm and hand function in multiple sclerosis (MS) patients with moderate-to-severe spasticity, according to a small pilot study in Italy. Notably, after nabiximols, patients showed…

EHP-101, an experimental treatment being clinically tested for multiple sclerosis (MS), activates a cellular signaling pathway that promotes blood vessel development and reduces inflammation following brain injury, a new study shows. The findings continue to support the use of EHP-101 in MS, a condition marked by excess inflammation and…

Among children and adolescents with multiple sclerosis (MS), treatment with Tecfidera (dimethyl fumarate) resulted in less disease activity on MRI scans and fewer relapses, compared with Avonex (interferon beta-1a), according to new data from the CONNECT Phase 3 trial. Researchers noted the lack of disease-modifying therapies…

Electrical stimulation of the brain through electrodes placed on the scalp may ease some measures of spasticity for people with relapsing-remitting multiple sclerosis (RRMS), according to results from a small clinical trial. Using this novel route of brain stimulation was shown to impact muscle contractions in patients with spasticity…

A quick MRI-based method called SyMRI may be useful in future clinical trials to test experimental myelin-repairing therapies in diseases like multiple sclerosis (MS), a new study shows. The study, “Quantification of individual remyelination during short-term disease course by synthetic magnetic resonance imaging,” was published in Brain…

The Overall Disability Response Score, a combination of three different assessments of disability, could be used to more accurately evaluate the effectiveness of treatments in multiple sclerosis (MS) clinical trials, a new study illustrates. The score is composed of three measures commonly used to assess disability in MS, which…

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…

Treatment with GA Depot, an experimental long-acting form of glatiramer acetate that requires less frequent dosing than approved formulations, significantly reduced relapse rates among people with relapsing forms of multiple sclerosis (MS), according to top-line results from a Phase 3 clinical trial. “We are pleased with the topline…

NurOwn, a stem cell therapy being developed by BrainStorm Cell Therapeutics, showed a good safety profile among people with progressive forms of multiple sclerosis (MS) in an open-label Phase 2 clinical trial, according to new data. The data show the experimental therapy also was associated with promising effects on…

Long-term treatment with Tysabri (natalizumab) significantly improves cognitive function and increases the chance of disability reduction in people with early relapsing-remitting multiple sclerosis (RRMS), according to data from the four-year observational STRIVE trial. Patients on Tysabri also reported improved quality of life and less impact of MS on…

Long-term treatment with Ponvory (ponesimod) safely and effectively reduces the rate of relapses, slows disability worsening, and prevents brain volume decline in adults with relapsing-remitting multiple sclerosis (RRMS). That’s according to eight years of data from patients enrolled in a now-completed Phase 2 clinical trial (NCT01006265) and its…

Treatment with the experimental B-cell depleting therapy ublituximab significantly outperformed Aubagio (teriflunomide) at reducing relapse rates and the number of lesions in people with relapsing forms of multiple sclerosis (MS), according to updated data from the Phase 3 ULTIMATE clinical trials. The two medications had comparable effects…

Publicity in national news outlets and an online self-screening questionnaire helped improve recruitment for a clinical trial in secondary progressive multiple sclerosis (SPMS), a new study highlights. “We have described our experience of recruiting participants with SPMS into two large RCTs [randomized clinical trials] in order to identify areas…

CNM-Au8, Clene Nanomedicine’s experimental oral therapy, safely and effectively improves vision and neurological function in adults with stable relapsing-remitting multiple sclerosis (RRMS) and disease-related visual impairment. Those are the findings of the VISIONARY-MS Phase 2 clinical trial (NCT03536559), a proof-of-concept study that investigated CNM-Au8 in people with…

By engaging a variety of stakeholders from across the multiple sclerosis (MS) community, researchers in the U.S. Deep South were able to enroll more than 800 patients to a clinical trial in just over two years in what’s considered the largest study of an exercise intervention in MS patients…

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…

Two years of treatment with Ocrevus (ocrelizumab) outperformed Rebif (interferon beta-1a) at preventing myelin loss in people with relapsing multiple sclerosis (MS), according to a new analysis of data from the OPERA II clinical trial. Ocrevus’ protection against demyelination was observed both in MS lesions,…

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…

Calyx and Qynapse have joined forces to expand the use of artificial intelligence (AI)-based neuroimaging tools in clinical trials of treatment candidates for conditions affecting the central nervous system (CNS), or the brain and spinal cord. This is expected to help advance therapy development for multiple sclerosis…