clinical trials

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…

An interactive, psychotherapy-based online program known as Elevida can effectively reduce fatigue in patients with multiple sclerosis (MS), results of a clinical study show. In their study, “Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis,” published in the Journal of Neurology,…

The laboratory-generated antibody GNbAC1 continued to limit brain shrinkage a year after relapsing-remitting multiple sclerosis patients began receiving it, its developers announced. GeNeuro and Servier were reporting on the 12-month results of a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody that destroys a harmful retroviral protein called pHERV-W which scientists have…

Topline results of an exploratory Phase 2 clinical trial revealed that Flex Pharma‘s treatment candidate FLX-787 improves muscle cramps, spasms and muscle stiffness in patients with multiple sclerosis (MS). The double-blinded trial, conducted in Australia, evaluated an oral dose of 19 mg FLX-787, taken twice daily in liquid…

Siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. An article about the Novartis therapy’s trial results appeared in the journal The Lancet. The title is “Siponimod versus placebo in secondary progressive multiple sclerosis…

Blood stem cell transplants lead to significant improvements in relapsing-remitting multiple sclerosis patients’ disability, a Phase 3 clinical trial shows. The 110 patients who took part in the MIST study (NCT00273364) were having relapses after receiving standard therapies such as beta interferon, Copaxone (glatiramer acetate), Novantrone (mitoxantrone), Tysabri (natalizumab), Gilenya (fingolimod),…

Treatment with umbilical cord stem cells was found to be safe and leads to sustained improvements in disability and brain lesions of multiple sclerosis (MS) patients, according to a clinical trial. The study, “Clinical feasibility of umbilical cord tissue-derived mesenchymal stem cells in the treatment of multiple sclerosis,” was…

Merck KGaA’s evobrutinib led to significant reductions in relapsing multiple sclerosis patients’ brain and spinal cord lesions, compared with a placebo, a Phase 2b clinical trial showed. Researchers measured the number of lesions at weeks 12, 16, 20 and 24. Evobrutinib, also known as M2951, is an oral inhibitor of…

An exploratory Phase 1/2 clinical trial in primary progressive multiple sclerosis (PPMS) conducted at the National Institutes of Health (NIH) confirms the safety profile of Raxone (idebenone) at a dose of 2,250 mg daily over two years. But no difference in effectiveness was found between the Raxone-treated group and…

A stem cell treatment improved the neurological symptoms of three-fourths of the multiple sclerosis patients in a Phase 1 clinical trial, New York researchers reported. The results prompted the team at the Tisch MS Research Center of New York to start a Phase 2 trial to further assess the therapy’s…

Deep-brain stimulation, a non-invasive way of targeting neurons in the cortex, can significantly ease symptoms of fatigue in multiple sclerosis (MS) patients, research drawn from a clinical trial suggests. These results, published in the journal Neurology: Neuroimmunology and Neuroinflammation, are in an article titled “Safety and preliminary efficacy of deep…

#ACTRIMS2018 – Third Course of Lemtrada Improves Relapse, Disability in MS Patients, CARE-MS II Trial Shows The normal treatment regimen with Lemtrada is a series of two treatment courses, with the second infusion course given 12 months after the first. A “selling point” for this disease-modifying therapy (DMT) is…

Multiple sclerosis (MS) patients who experience a relapse after two courses of Lemtrada (alemtuzumab) treatment showed improvements in relapse rate and disability after a third Lemtrada course, according to results of the CARE-MS II trial extension. The poster reporting the findings, titled “Efficacy of Alemtuzumab Retreatment in Patients Who Experienced Disease Activity after…

A combination of an anti-viral therapy and the anti-depressive mirtazapine can stop the worsening of an infection linked to the multiple sclerosis therapy Tysabri (natalizumab), a case study suggests. The infection, John Cunninghan polyomavirus, can cause a potentially fatal brain infection known as  progressive multifocal leukoencephalopathy, or PML. Both…

Celgene’s Ozanimod reduces relapsing multiple sclerosis patients’ relapses, brain lesions, and brain volume loss, a Phase 3 clinical trial shows. The company presented the results of the SUNBEAM trial at the ACTRIMS Forum 2018 convention in San Diego, Feb. 1-3. The presentation was titled “Ozanimod Demonstrates Efficacy and Safety…

MedDay Pharma’s MD1003 leads to long-lasting improvements in progressive multiple sclerosis patients’ disability, a Phase 3 clinical trial follow-up study shows. Researchers presented the results at the third Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, Feb. 1-3. The poster presentation was titled “…

The walking speed of multiple sclerosis patients taking Adamas Pharmaceuticals’ ADS-5102 (amantadine) increased by 16.6 percent more those taking a placebo, a Phase 2 clinical trial reports. Another finding was that more of the treated patients increased their walking speed by 20 percent or more during the four-week trial. The study,…

Top-line results from a clinical trial evaluating the investigational oral therapy ibudilast for progressive multiple sclerosis (MS) show that the therapy led to a significant reduction of brain atrophy in patients when compared to controls. Robert Naismith, MD, one of the study’s principal researchers from Washington University in St. Louis,…

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."

TG Therapeutics‘ ublituximab (TG-1101) led to a remarkable reduction in multiple sclerosis patients’ brain and spine lesions, a Phase 2 clinical trial showed. In fact, none of the treated patients had new gadolinium-enhancing lesions — or damaged nerve cell areas — six months after treatment, researchers said. Their analysis covered patients…

Dutch regulators have signed off on AXIM Biotechnologies’ clinical trial plans for a chewing gum that offers controlled release of cannabinoids to treat multiple sclerosis patients’ pain and spasticity. The Dutch Medicines Evaluation Board’s sign-off on MedChew Rx means AXIM can start trials. A leader in cannabinoid research, New York-based AXIM…

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…

A Phase 3 clinical trial evaluating AB Science’s masitinib as a treatment for progressive multiple sclerosis can continue without having to add patients, an independent review board has decided. The decision indicates that the therapy has been effective enough that its population base does not need to be expanded, the…

MMJ International Holdings is seeking a patent for a part-cannabinoid and part-non-cannabinoid treatment for multiple sclerosis and other diseases. The company said in a news release that it filed the patent request ahead of Phase 2 clinical trials of the formulation.  The therapy was developed by MMJ Bioscience, an affiliate of MMJ International…

Clomipramine, an approved antidepressant, shows potential in treating people with progressive multiple sclerosis (MS)  — a disease form with few treatments — by protecting nerves from various processes thought to underly progressive MS, early research shows. The lab and animal study, which focused on already-approved treatments, was titled “Systematic…

Using balloons to enlarge veins so that more blood flows out of the brain and spinal cord fails to help multiple sclerosis patients, according to a clinical trial in Italy. Researchers said the procedure did not improve their functioning or reduce their brain lesions — areas where toxic protein build-ups…

 Novartis' Gilenya and interferon beta-1b-based therapies stop multiple sclerosis patients' cognitive decline, a Phase 4 clinical trial shows. Gilenya (fingolimod) also reduces patients' relapses and the number of their brain lesions — areas where a protein coating that protects nerve cells has deteriorated, researchers found.

Scientists announced positive and encouraging outcomes from two clinical studies — running as part of the larger Human Vaccines Project — aiming to unravel the mechanisms that underlie our immune system’s ability to fight disease. The results are expected to shed light on unknown aspects of the immune system that scientists at the Human Vaccines Project, a public-private partnership, hope to translate into new trials for diseases linked to the immune system, such as multiple sclerosis. Results from the trials — the Human Immunome Program and the Immunity to Hepatitis B Vaccine study — were recently presented at the World Vaccine and Immunotherapy Congress in San Diego, California. In the ongoing Human Immunome Program, researchers are trying to fill a major knowledge gap in the components and mechanisms of the immune system that allow it to recognize various threats, from viruses, parasites and bacteria to cancer cells. They are using blood samples from healthy people to analyze, at an unprecedented depth, the whole repertoire of genes that make up the surface receptors of immune B- and T-cells, the core cells of the immune system’s defence mechanisms. Results will likely advance how scientists diagnose and treat various diseases, and could prompt the development of new, improved vaccines. "We are studying the immune systems of healthy individuals to identify common elements, which could be important for facilitating new and improved vaccines," James E. Crowe Jr., MD, director of Vanderbilt University Medical Center's Vaccine Center, the leading scientific institution of the Human Immunome Program, said in a press release. Researchers will cross the sequencing information with participants' microbiome composition — the natural community of microbes that reside in an organism and are key for a healthy immune system — and other health and sociodemographic characteristics. "We also plan to expand these studies to complete the catalog across different demographics and geographies and compare healthy subjects with individuals with immune-mediated diseases such as multiple sclerosis, cancer and Alzheimer's, which could also reveal novel diagnostic markers," Crowe said. The second study, the Immunity to Hepatitis B Vaccine trial — currently recruiting participants — aims to understand why some people achieve protection against Hepatitis B after a single vaccine shot, while others require up to three immunizations to acquire full immunity. Understanding why the immune system responds differently in individuals can help researchers improve existing vaccines and potentially lead to one-shot vaccines that provide long-term immunity for all populations. Researchers in this study are analyzing genes belonging to the innate-immune system — a general immune system response, not one tailored to specific threats — and observing that activation of these genes in certain immune cells can predict who will be a responder after a single shot of the Hepatitis B vaccine. Preliminary results of the Immunity to Hepatitis B Vaccine study were delivered in two separate sessions at the congress. One was given by Manish Sadarangani, director of the Vaccine Evaluation Center of the University of British Columbia and BC Children's Hospital Research Institute, and the by and Richard Scheuermann, director of the J. Craig Venter Institute in La Jolla, California. "These preliminary data points toward strategies to understand why some people respond better to vaccines than others," Sadarangani said. "Using single cell analyses, we now have the opportunity to probe vaccine-induced responses more effectively, to not only learn what happens immediately after vaccination, but to monitor responses over time and utilize machine learning to eventually predict the human immune response to vaccines," added Scheuermann. Wayne C. Koff, president and chief executive officer of the Human Vaccines Project, emphasized that researchers are optimistic with the results obtained so far, as they "provide important insights into the scale and complexity of the human immune system and how vaccines confer protective immunity." "With our network of academic and corporate partners, we aim to build on these findings and decode the human immune system, giving the world the tools required to advance the development of future vaccines and therapies to defeat major global diseases," Koff concluded.