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…
Trial recruitment
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…
Phase 2 Trial of NurOwn Stem Cell Therapy in Progressive MS Planned for US, BrainStorm Announces
BrainStorm Cell Therapeutics is planning to launch a Phase 2 clinical trial in the United States to evaluate the safety and activity of its lead cell therapy candidate, NurOwn, in people with progressive multiple sclerosis (MS). The company announced that has submitted an Investigational New Drug (IND) application to…
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),…
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 new clinical trial will be the first in the world to recognize the importance of retaining hand function for wheelchair-bound patients with primary progressive MS (PPMS), according to a press release from Queen Mary University of London. The international trial, which will be conducted by a…
MMJ Bioscience Files Request with FDA to Open Phase 2 Study of Medical Cannabis in Progressive MS
MMJ Bioscience, which specializes in medical cannabis products, has filed a request with the U.S. Food and Drug Administration (FDA) to open Phase 2 clinical trials evaluating the company’s THC/CBD pharmaceutical compounds as possible treatments for symptoms of multiple sclerosis (MS). THC refers to the tetrahydrocannabinol compound, part of the…
Oryzon Genomics will give updates on its leading investigational product ORY-2001, a brain-targeting epigenetic therapy now in a Phase 2 clinical trial recruiting multiple sclerosis patients, at a series of scientific conferences. According to a press release, these include two conferences in the United States, the 2018 BIO…
Complications from Gilenya Treatment Managed Successfully, Case Report Says This wasn’t a minor complication. It was a version of PML, a brain disease that can be fatal. PML is also a known side effect of Tysabri, so the report of a successful treatment should be important to…
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…
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."
Flex Pharma has completed enrolling multiple sclerosis patients in a Phase 2 clinical trial in Australia testing FLX-787’s ability to alleviate muscle stiffness, spasms, and cramps. The compound has a mechanism of action that Flex believe will generate fewer side effects than other muscle-relaxing medications. The company is also…
Research teams from Canada, Portugal and the United States, each with projects focused on predicting and defining characteristics of multiple sclerosis (MS) , will share this year’s 1 million euro ($1,165,700) Grant for Multiple Sclerosis Innovation (GMSI), announced by Merck at the 7th Joint ECTRIMS-ACTRIMS meeting in Paris, France,…
Researchers at Duke University want to determine if data collected through an iPhone app can ably capture individual experiences in people with multiple sclerosis to improve doctor-patient communication and overall disease understanding. According to a National MS Society report, the researchers want to investigate the benefits combining mobile phone-based data with machine learning (the ability of a smartphone to mimic human behavior) and patient participation. The study is currently enrolling MS patients, 18 or older, live in the United States and be able to read and understand English. Participants must own or have daily access to an iPhone (iOS 9 or greater) to download a free, MS Mosaic app from the Apple Store. The app is not yet available for Android phones. The rationale behind the study is that MS can be an extremely complex condition, with symptoms ranging from numbness, walking difficulty, to vision impairment and fatigue. Each patient's experience is different and can be affected by medication, emotional health, and environmental factors. This complexity can complicate research. Study participants will receive daily, weekly and monthly questionnaires to fill about their symptoms. Daily surveys should take no longer than a minute to complete, and weekly surveys about ten minutes. Initial registration should take about 20 minutes, the NMSS report says. In some of the surveys, participants will be asked to perform specific tasks while holding or using the mobile phone, like walking 25 steps, turning around, then walking back 25 steps – while holding the phone. Other tests include tapping on the phone screen repeatedly to test motor speed, coordination and fatigue, or playing a pattern game to assess short-term memory. These tasks should take about five minutes each. Patients can choose not to answer some of the questions or to participate in certain tasks. All information is collected through the app, and will be sent to a secure data server. Participants can export data to share with a healthcare provider. Each person will be identified by a code, and data will be analyzed in a way that maintains confidentiality. Researchers, however, be able to identify a participant should they need to do so for "research integrity or legal purposes," the report states. Questions regarding this study can be answered by sending an email to [email protected].
MS News That Caught My Eye: Diagnostic Blood Test, Fatigue, New Trials and Stem Cell Therapy
IQuity Taking Orders for RNA-based Blood Test That Can Detect MS Early with 90% Accuracy Can it be that there’s now a blood test that can help diagnose MS? This company says it has one and doctors can order it. For a disease that’s always been…
TG Therapeutics is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab) as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, a glycoengineered monoclonal antibody, with Genzyme’s Aubagio…
University of Southern California researchers are recruiting 400 Hispanics who have been diagnosed with multiple sclerosis in the past two years for a study about genetics’ and cultural perceptions’ effect on the severity of the disease. More specifically, the Keck School of Medicine team will look at whether the stressful process of…
Nortis Awarded $688K Grant from NIH to Develop ‘Living’ Model of Blood-Brain Barrier for Research
Nortis, a Seattle-based biotech company, has received a $688,000 grant by the National Institutes of Health to create a living, 3-D model of the human blood-brain barrier that will be used for laboratory testing to accelerate drug development and lessen the likelihood of failure in clinical trials. This grant provides funding for a third year of a Small Business Innovation Research (SBIR) award given to Nortis by the National Institute of Neurological Disorders and Stroke (NINDS), a branch of the NIH. SBIR provides grants to U.S.-based small businesses to do federal research and enable the commercialization of technology. The blood-brain barrier is a tissue barrier that only allows certain molecules to pass from blood vessels into the brain. It is a protective mechanism to prevent the entry of foreign bodies and infection-causing organisms in the brain. Researchers are trying to find ways of delivering medications across this barrier, to reach brain tissues to treat diseases that include multiple sclerosis. "Understanding how drugs are transported across the blood-brain barrier and interact with the brain presents a significant scientific challenge," Thomas Neumann, CEO of Nortis and principal investigator on the project, said in a press release. "More predictive preclinical models based on human tissue are urgently needed to reduce costs and minimize clinical trial failures," he added. "This grant will help us develop new in-vitro alternatives to traditional pharmaceutical drug development testing on laboratory animals."
I was surprised to see that a study of a potential MS drug labeled MD1003 is still accepting participants. It’s a study that I’d love to take part in, if only I was a few years younger. MD1003 is a high dose of biotin, a form of…
University of California at San Francisco Recruiting MS Patients for Gut Bacteria Study Last year, a Harvard study reported significant differences between bacteria that MS patients have in their bellies and that found in those who don’t have MS. If that bacteria is treated, those MS-related changes might…
Atara Biotherapeutics recently published an update of the company’s quarterly financial results and operational highlights, including the advancement of its T-cell based immunotherapy strategies for multiple sclerosis (MS) and cancer. One of the investigational therapies featured in the report is ATA188, a potential treatment for MS.
University of California medical school researchers are looking for multiple sclerosis patients who want to participate in an international study of the bacteria that live in our gut. The University of California at San Francisco team decided to study the gut microbiome after recent evidence suggested that it is critical in…
Bringing More Minority MS Patients into Research Is Project’s Goal, Starting with 15-Minute Survey
The MS Minority Research Engagement Partnership Network is calling for all multiple sclerosis (MS) patients, ages 21 and older, to respond to a 15-minute online survey. Investigators are hoping to better understand how people with MS from different ethnic backgrounds and races view medical research, so as to engage them in…
Phase 3 Study of High-Dose Biotin, MD1003, in Treating Primary and Secondary MS Patients Underway
A Phase 3 clinical trial has been launched by MedDay Pharmaceuticals to investigate whether treatment with high-dose biotin (MD1003) may ease disability and improve mobility in non-relapsing primary or secondary progressive MS patients. The study is recruiting participants across the U.S., Canada and Europe. Biotin is a form of…
A clinical trial of a smartphone app that helps multiple sclerosis (MS) understand and manage their disease — and to aid and speed research — is now recruiting people nationwide. Claimed to be the first of its kind, the app, called myMS, is designed to give MS patients quick and easy access to pertinent information, from clinical evaluations…
A global Phase 3 clinical trial assessing MD1003 — also known as high-dose biotin — for progressive multiple sclerosis (MS) might lead to the approval of one of the first treatments helping select progressive patients to improve. The trial aims to prove that high-dose biotin can reverse disability in non-active progressive MS.
A new clinical trial evaluating the effectiveness of extended-release baclofen capsules in relieving spasticity related to multiple sclerosis (MS) is calling for 135 people with any form of the disease. The study, taking place in six U.S. states, is sponsored by Sun Pharma, the drug’s developer. Baclofen, an approved MS…
Many MS patients are in the hunt for multiple sclerosis clinical trials for which they can volunteer. But those trials are not always easy to find. On the other hand, researchers complain it also can be difficult to find trial subjects. I was lucky. Back in…
Multiple Sclerosis Association, Antidote Technologies Collaborate to Raise Clinical-trial Awareness
The Multiple Sclerosis Association of America (MSAA) and Antidote Technologies announced a partnership to increase awareness about clinical trials on multiple sclerosis (MS) and to make important information more accessible. In addition to helping those with the disease, the effort aims to help companies planning trials to find participants for…
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