Trial recruitment

A clinical trial testing a computer program called Deprexis as a home-based therapeutic strategy for multiple sclerosis (MS)-related depression is enrolling participants with all types of MS  at three sites in the U.S. and two in Germany. The U.S. study locations are the Cedars-Sinai Medical Center,…

Phase 3 Trial of ADS-5102 Recruiting Participants of All MS Types This medication is similar to Ampyra (dalfampridine) because its goal is to improve walking in those with MS. It sure would be nice if we had another medication approved that could do that. Though this trial began recruiting…

A Phase 3 trial testing ADS-5102 (amantadine) extended release capsules in all types of multiple sclerosis (MS) is enrolling participants to determine whether the oral therapy can improve walking speed. A total of 570 adults with MS, ages 18 to 70 years, who have difficulty walking will be…

The first patient has been enrolled in a Phase 2 multicenter clinical trial testing the use of NurOwn cellular therapy to treat progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics announced. The open-label trial (NCT03799718), titled Safety and Efficacy of Repeated Administration of neuron (MSC-NTF Cells) nin Participants…

The Cleveland Clinic Nevada is recruiting participants for DELIVER-MS, a clinical trial comparing two common treatment approaches for relapsing-remitting multiple sclerosis (RRMS). Results from the DELIVER-MS trial, titled “Determining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis” (…

The National Multiple Sclerosis Society is funding a new Phase 2 clinical trial to test the effectiveness of stem cell therapy on individuals with progressive forms of multiple sclerosis (MS), using mesenchymal stem cells from their own bone marrow. The ability of stem cells to both self-renew and create…

Immunic Therapeutics has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy for relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role…

It is a question that multiple sclerosis (MS) patients, loved ones, and the larger community have asked for some time: “Will there be a cure for multiple sclerosis?” MS News Today had the opportunity to ask that question of leaders at the Americas Committee for Treatment and Research in…

BrainStorm Cell Therapeutics announced the Cleveland Clinic is the first clinical site contracted in the United States for the Phase 2 multi-center study evaluating the company’s NurOwn mesenchymal stem cell (MSC) therapy in individuals with progressive multiple sclerosis (MS). “We are very excited to announce The Mellen Center for…

A clinical trial to test the effects of antioxidant treatment with lipoic acid on progressive forms of multiple sclerosis (MS) is recruiting 118 participants at seven sites in North America. The study sites include: Birmingham, Alabama; Burlington, Vermont;  Portland, Oregon; Salt Lake City, Utah; Seattle, Washington; Washington, D.C., and;…

WeHealth, PathMaker Collaborating to Develop MyoRegulator as Noninvasive Treatment for Spasticity I’m one of the many people with multiple sclerosis (MS) for whom spasticity is a significant problem. This is a nonmedicinal approach to dealing with it. I hope it doesn’t take too long to make this…

Exercise and multiple sclerosis are a natural pair and shown by research to be an important part of our MS care plan. We all can benefit from getting an assessment by a professional therapist and having an exercise plan customized for our MS, but accessing exercise in a…

Because multiple sclerosis (MS) presentation and progression course can be very different between people of African ancestry and Caucasians, the recruitment of minorities to Phase 3 clinical trials is of particular importance. Researchers in the MS field and the general MS community should make a greater effort to improve…

With a renowned researcher and her team chosen to lead it, work can now begin on the first project of its kind in Canada designed to shed more light on multiple sclerosis progression, and better ways of diagnosing and treating it. Leading the pioneering $7 million project — the Canadian…

Hoping to expedite multiple sclerosis (MS) research and boost patient participation, the Accelerated Cure Project (ACP) for Multiple Sclerosis is teaming with the National Multiple Sclerosis Society. As part of the collaboration, the MS Society will make use of ACP’s iConquerMS, a research initiative to increase the engagement…

A Phase 3 clinical trial intending to confirm the potential of MD1003, a high-dose biotin, in treating progressive multiple sclerosis (MS) patients is completely enrolled, MedDay Pharmaceuticals, the investigational therapy’s developer, announced. The randomized, double-blind, and placebo-controlled study (NCT02936037), called SPI2, follows the previous Phase 3 trial (NCT02220933),…

With a $5 million grant, the Multiple Sclerosis Society of Canada (MSSC) will support an 12-week international study to determine the effects of cognitive rehabilitation and aerobic exercise on those with progressive multiple sclerosis (MS), it was announced in a news release. The investigation is being touted as…

Researchers at Duke University are recruiting adults with multiple sclerosis (MS) for a study evaluating whether the use of a smartphone app that collects data can help capture the disease experience, improve communication with clinicians, and further an understanding of MS. The disease’s complex and varied symptoms means each patient…

A 12-week clinical study is recruiting people with relapsing-remitting multiple sclerosis (RRMS) to evaluate if intermittent fasting can improve their immune response, metabolism, and gut microbiome — the bacterial community that inhabits the gastrointestinal tract. Its findings may also hint at whether such a diet might ease MS symptoms or alter discourse course and, if used in conjunction with other treatments, boost their efficacy. Conducted by researchers at Washington University in St. Louis, Missouri, the trial is supported by their findings in an earlier mouse study.  Results showed that fasting worked to ease MS-like symptoms in a mouse model of the disease, the research team reported. Specifically, EAE mice fed every other day were less prone to symptoms that included difficulty in walking, limb weakness, and paralysis than mice allowed to eat freely.  A fasting diet also enriched bacterial diversity in the mice guts, and shifted immune cell populations there toward a lower inflammatory response. When gut bacteria were transferred from fasting mice to nonfasting mice, the later also were seen to be better protected against MS-like movement problems, supporting the influence of the gut microbiome on MS symptoms. Several diets have been proposed to help ease disease progression in MS patients, but solid scientific evidence is lacking to support any one diet over another, leaving the issue much to an individual’s choice. “The fact is that diet may indeed help with MS symptoms, but the studies haven’t been done,” Laura Piccio, MD, an associate professor of neurology at WUSTL and the study's lead author, said in a WUSTL news release written by Tamara Bhandari. Taking place at the Missouri university, the trial is expected to enroll 60 RRMS patients. Half will be randomly assigned to eat a standard Western-style diet seven days a week, and the other half to Western-style diet five days a week, with two days set aside for fasting (consuming a maximum of 500 calories each day). On fasting days, patients can only drink water or calorie-free beverages and eat fresh, steamed or roasted non-starchy vegetables All will undergo a neurological assessment, and provide blood and stool samples in the study's beginning, at mid-point or week six, and at its end (week 12). Those using MS medications will continue on their prescribed treatment regimens throughout the study. More information, including enrollment information, is available here. Piccio noted that a pilot study on diet in 16 MS patients showed that limiting calories every other day for two weeks led to immune and gut microbiome changes that resembled those observed in the mice study she helped to lead. Its researchers concluded that intermittent fasting had the potential to positively manipulate the immune response in MS patients by changing their gut microbiome. The gut microbiome plays a central role in digestion, and in producing vitamins and amino acids (the building blocks of proteins). But a growing body of evidence indicates that it also determines how our immune systems develops and matures. Indeed, an increasing number of studies link irregularities in the gut microbiome with MS. “There are several possible ways fasting can affect inflammation and the immune response,” Piccio said. “One is by changing hormone levels. We found that levels of the anti-inflammatory hormone corticosterone were nearly twice as high in the fasting mice. But it also could act through the gut microbiome.” The new trial will allow the team to analyze more deeply the effects of a fasting diet — and perhaps gather evidence for a larger study investigating if skipping meals can ease MS symptoms. Its goal is to find out "whether people on limited fasts undergo changes to their metabolism, immune response and microbiome similar to what we see in the mouse,” Piccio said. “I don’t think any physician working with this disease thinks you can cure MS with diet alone,” she added, “but we may be able to use it as an add-on to current treatments to help people feel better.”

A first patient has been enrolled in a single-site trial to evaluate the potential of electrical stimulation, called  Electroceutical Therapy, in reducing brain injury, Endonovo Therapeutics, the therapy’s developer, announced. Electroceutical Therapy is a non-invasive and wearable electronic device that uses pulsed electromagnetic fields (PEMF) to stimulate the central nervous system.

A Johns Hopkins University-initiated clinical trial is starting to enroll an estimated 900 relapsing-remitting multiple sclerosis (RRMS) patients to assess the benefits of switching therapies to prevent or reduce disability. The TREAT-MS study (NCT03500328) will evaluate whether RRMS patients with disease activity while on a traditional first-line disease-modifying therapy…

A Phase 3 trial testing an oral once-a-day therapy — ADS-5102 (amantadine) extended release capsules — in multiple sclerosis (MS) patients with walking difficulties has enrolled its first participant, Adamas Pharmaceuticals announced. The multi-center, double-blind study (NCT03436199) will assess ADS-5102 in about 570 such patients at five sites…

The Accelerated Cure Project for Multiple Sclerosis and a Regeneron unit are teaming up to sequence the coding portion of genes in DNA samples of multiple sclerosis and other patients in the project’s repository. The cure project is a non-profit organization whose goal is to accelerate research to improve MS diagnosis and…

Engaging all types of people for research isn’t just a nice thought. It is critical to obtaining research results that will be meaningful. Middle-aged white women are often the people who volunteer for studies. Men, young people, and most significantly, people of color, lack representation in studies. According…

The Phase 2a trial of GA Depot (glatiramer acetate) for the treatment of primary progressive multiple sclerosis (PPMS) has dosed the first patient, Mapi Pharma recently announced. In the U.S., Copaxone (glatiramer acetate injection, marketed by Teva Pharmaceutical) is the standard therapy for relapsing-remitting multiple sclerosis (RRMS), which is…

Oryzon Genomics has enrolled the first multiple sclerosis patient in its Phase 2a SATEEN clinical trial investigating the therapy ORY-2001. The Spanish company will also present new results from preclinical models of MS treated with ORY-2001 at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018, set for Feb. 1-3 in San Diego. ORY-2001 is an epigenetic therapy, meaning it targets the expression and activity of genes. The drug inhibits two particular molecules, LSD1 and MAOB, and was previously shown to reduce cognitive impairment and neuroinflammation in preclinical models, including in a mouse model of MS — the experimental autoimmune encephalomyelitis (EAE) model. The therapy was also shown to have neuroprotective effects. During ACTRESS 2018, Oryzon's chief scientific officer, Tamara Maes, will present a poster, "ORY-2001 reduces inflammatory cell infiltration in the Theiler’s murine encephalomyelitis virus model and highlights the epigenetic axis in MS.” “In previous reports we showed that ORY-2001 reduces the clinical score, lymphocyte egress, immune cell infiltration and inflammation protecting the spinal cord from demyelination in a murine MS-EAE model,” Maes said in a press release. “Here we provide data on the efficacy of ORY-2001 in the Theiler’s murine encephalomyelitis virus model for multiple sclerosis." In a second poster, "ORY-2001 in multiple sclerosis: first clinical trial of a dual LSD-1/MAOB inhibitor,” Roger Bullock, Oryzon's chief medical officer, will detail the Phase 2a trial, SATEEN, testing ORY-2001 in patients with relapsing-remitting or secondary progressive MS over a 36-week period, followed by an open-label extension. “Our first patient enrolled in SATEEN signals a new landmark for the clinical development of this drug in different neurological indications,” said Bullock. “This is the first epigenetic approach in this disease, and we hope that it will contribute to enlarge and improve the therapeutic options for patients afflicted by MS."

Mallinckrodt Pharmaceuticals is seeking 66 participants for a clinical trial to determine the safety and effectiveness of its injected therapy H.P. Acthar Gel as a treatment for acute relapses in people with relapsing-remitting multiple sclerosis (RRMS). MS relapses are flare-ups of central nervous system inflammation that damage the myelin coating that protects nerve cells. The damage disrupts the transmission of impulses between the cells, causing spikes in MS symptoms. For severe relapses that interfere with a person’s mobility, safety or ability to function, most neurologists recommend corticosteroid treatment administered intravenously or taken orally. Steroids can also be administered by injection of a gel under the skin. H.P. Acthar Gel is designed to provide extended release of steroids in the body. The trial will evaluate whether the gel is an effective treatment for RRMS patients who have been unable to recover from a relapse after receiving high-dose intravenous or oral steroids. Researchers will randomly assign participants to receive either H.P. Acthar Gel or a placebo, delivered by injection once a day for 14 days. Follow-up visits will be required at 14, 28 and 42 days. The study's main objective will be seeing whether patients' disability improves. Researchers will use a standard tool for measuring disability known as the Expanded Disability Status Scale.  Other objectives will include seeing how the therapy affects patients' fatigue, quality of life, workplace productivity, and use of healthcare resources. Participants must have a confirmed diagnosis of RRMS, be older than 18 years of age, and have experienced a relapse within 29 days of enrolling in the trial. For more information about enrollment criteria and how to participate in the trial, please contact Valerie Carvajal at (800) 556-3314 or by email at [email protected]. The National Multiple Sclerosis Society announced in an MS trial alert that Mallinckrodt will be  enrolling participants in Tucson; Fort Collins, Colo.; Tampa; Atlanta; Savannah, Ga.; Northbrook, Ill.; Fort Wayne, Ind.; Indianapolis; Kansas City, Kan.; New York; Cleveland; Dayton, Ohio; Dallas; Round Rock, Texas; San Antonio; Salt Lake City; Richmond, Va.; and Tacoma, Wash. Without clinical trial participation there is no way for patients to obtain new medicines or for scientists to ultimately find a cure for MS. The National MS Society encourages participation. It has developed a guide for patients who want to take part in studies called “Participating in Clinical Trials.” It covers the basics of participation, benefits versus risks, patient protection, costs and other important issues about trials.  

Atara Biotherapeutics has received a green light to enroll U.S. patients into a Phase 1 trial of ATA188 for progressive or relapsing-remitting multiple sclerosis (MS). The study was initially launched in Australia, but with the U.S. Food and Drug Administration (FDA) having cleared the company’s application, the trial…

Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate) in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartis’ Gilenya (fingolimod) — making immune…

A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy, with the University of Colorado School of Medicine, presented the study at…