clinical trials

Multiple sclerosis (MS) patients who experienced a relapse between their first and second rounds of Lemtrada (alemtuzumab) had good treatment outcomes over the long run, according to a Phase 3 clinical trial. Those who relapsed after their first round ended up with annual relapse rates similar to those who didn’t…

Fampyra (prolonged-release fampridine tablets) — sold in the U.S. as Ampyra (dalfampridine) — has now been granted standard marketing authorization in Europe. The approval was based on the results of a Biogen-sponsored Phase 3 clinical trial confirming the drug’s safety and efficacy in improving walking in patients with multiple…

Relapsing multiple sclerosis (RMS) patients taking the investigational drug ozanimod, also known as RPC-1063, had lower relapse rate than those on weekly Avonex (interferon β-1a) therapy, according to Celgene in an announcement updating results of its Phase 3 RADIANCE trial. Ozanimod is a new orally administrated drug that selectively inhibits the…

A real-world medical-facilities setting has confirmed clinical trial findings that Gilenya (fingolimod) can reduce multiple sclerosis relapses, according to a Spanish study published in Plos One. Gilenya, developed by Novartis Pharmaceuticals, was the first oral disease-modifying therapy to obtain U.S. and European approval. The Food and Drug Administration and European Medicines Agency authorized…

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…

Recently approved, Ocrevus (ocrelizumab) should now be available nationwide for patients prescribed the therapy. But as with any new treatment, concerns about safety and practical issues are on many patients’ minds. Multiple Sclerosis News Today asked Dr. Jack Burks — a neurologist and researcher who serves as chief…

The National Multiple Sclerosis Society is pumping $17 million into 43 research projects that represent almost half of its $40-million research funding commitment in 2017. Among the projects are trials evaluating intermittent fasting as a way to harness inflammation and stem cell research. A growing number of studies indicate that stem cells can slow…

The National Multiple Sclerosis Society (NMSS), together with its British partners, plans to launch a Phase 3 trial in the next few months to investigate whether simvastatin — a cheap drug that controls cholesterol levels — may be a suitable treatment for people with secondary progressive multiple sclerosis (SPMS). The trial,…

Laquinimod failed to meet its primary Phase 3 clinical trial objective of slowing the progression of relapsing-remitting multiple sclerosis (RRMS) after three months, according to its developers, Teva Pharmaceutical Industries and Active Biotech. That has prompted the partners to abandon their quest to use the therapy to treat RRMS. Laquinimod…

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.

Lemtrada (alemtuzumab) may be more effective in preventing relapses in multiple sclerosis patients than the newly approved Ocrevus (ocrelizumab), according to a study presented April 28 at the American Academy of Neurology (AAN) 2017 Annual Meeting in Boston. The study, supported by Sanofi Genzyme and Bayer HealthCare Pharmaceuticals, compared…

I knew it was only a matter of time before my MS neurologist would have MS PATHS available to collect clinical data from people who have agreed to participate. MS PATHS is an information- and biological sample-gathering clinical study from Biogen, the leading manufacturer of multiple sclerosis disease-modifying…

Within the first two months of treatment, Ocrevus (ocrelizumab) reduced relapses in multiple sclerosis (MS) patients by more than half compared to those on Rebif, and almost completely prevented new brain lesions, according to data underscoring the drug’s rapid effects. Researchers from San Francisco-based Genentech and its Swiss parent…

Real-world data of treatment with Tecfidera (dimethyl fumarate) and Tysabri (natalizumab) in relapsing multiple sclerosis (MS) patients suggest that treatment at early disease stages improves outcomes and prevents disability development. The studies, presented by Biogen at the American Academy of Neurology 2017 Annual Meeting in Boston, might challenge the…

While many multiple sclerosis patients celebrated the recent approval of Ocrevus (ocrelizumab), others argued that the drug is largely a rebranded version of rituximab. Rituximab — sold as Rituxan for indications like non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis — is used off-label to treat relapsing MS. In online forums and social media,…

A prominent neurologist, who was involved in early research into B-cell therapy, tells Multiple Sclerosis News Today about his positive experience of using ocrelizumab, now branded Ocrevus, with patients. Michael Racke, MD, Department of Neurology at The Ohio State University Wexner Medical Center took time to talk with me about…

Ocrevus is a “fabulous” drug that does wonders for those who respond to it. That’s the view of an MS nurse practitioner in Florida, with whom I spoke this week. Tricia Pagnotta works at the Multiple Sclerosis…

Ocrevus (ocrelizumab), now approved for both relapsing and primary progressive multiple sclerosis (MS), is expected to become available in the coming week. While patients and neurologists are waiting, Multiple Sclerosis News Today spoke to Genentech about the treatment’s approval, future research plans, and what patients can expect in terms…

Four newly published articles, the focused work of a group of researchers, evaluate the validity of four outcome measures commonly used in clinical trials of multiple sclerosis (MS) to set standards for such measures, the National MS Society recently reported. The effort by the Society-sponsored MS Outcome Assessments Consortium…

The potential approval of Ocrevus (ocrelizumab) this month supports the idea that, someday, a world free of multiple sclerosis (MS) is possible, according to Dr. Tim Coetzee, the National Multiple Sclerosis Society’s chief advocacy, services and research officer. While Coetzee — and the society he represents — realize the potential of…

Here is a transcript of Multiple Sclerosis News Today‘s interview with Dr. Tim Coetzee — chief advocacy, services and research officer for the National Multiple Sclerosis Society — about the importance of the U.S. Food and Drug Administration (FDA)’s awaited decision on Ocrevus (ocrelizumab), and the other ongoing research. Tim…

Ocrevus (ocrelizumab), an investigational monoclonal antibody, significantly decreases disease activity in patients with multiple sclerosis (MS), and is associated with a higher proportion of patients reaching no evidence of disease activity (NEDA), according to a new analysis. The study, “NEDA analysis by epoch in patients with relapsing multiple…

A detailed analysis of relapsing and primary progressive multiple sclerosis (MS) patients in the three Phase 3 trials of Ocrevus (ocrelizumab) showed that the treatment did not significantly increase their risk of infections — serious or otherwise. Certain infections, including common colds and influenza, were numerically more common among Ocrevus-treated patients,…

The French economic promotion agency Bpifrance has awarded Boston-based PathMaker Neurosystems a grant to finance the development of its MyoRegulator, a noninvasive neurotherapy technology to treat conditions linked to neural pathway disruption, including neuromotor spasticity in patients with multiple sclerosis (MS). Through the Programme d’Investissements d’Avenir (PIA-1), an investment program offered by Bpifrance, the  grant — whose…

The world’s first registry for patients with multiple sclerosis (MS) and other autoimmune diseases (ADs) has gone online, to honor National Autoimmune Disease Awareness Month in March. The Autoimmune Research Network (ARNet) is a creation of the Michigan-based American Autoimmune Related Diseases Association (AARDA), which is collaborating with the National Coalition of…

PathMaker Neurosystems and the Brain and Spine Institute (ICM) in Paris will collaborate on human clinical trials to secure CE Mark clearance for PathMaker’s MyoRegulator PM-2200, a noninvasive neurotherapy technology to treat conditions linked to neural pathway disruption, including multiple sclerosis (MS). CE Mark — which stands for “Conformité Européenne,” or European Conformity…

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…

Recently published data from three Phase 3 trials of Ocrevus (ocrelizumab) show that the investigational drug does what no other therapy has achieved so far — working to prevent disease in both relapsing and primary progressive (PP) forms of multiple sclerosis (MS). Publications in the New England Journal…

President Obama’s signing of the 21st Century Cures Act on Dec. 13 is expected to bring real change to those living with multiple sclerosis (MS). The legislation will lead to better research and clinical trials. It also puts increased weight on the role patients play in developing treatments for their…

Health Canada has approved Zinbryta (daclizumab) as a treatment for adults with active relapsing-remitting multiple sclerosis (RRMS), Biogen and AbbVie announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies. “ZINBRYTA™ is the first once-monthly, self-administered treatment…