clinical trials

Mallinckrodt has enrolled its first relapsing multiple sclerosis (MS) patient into a Phase 4 clinical trial (NCT03126760) with H.P. Acthar Gel (Repository Corticotropin Injection) to see if the therapy can help treat relapse symptoms in patients who did not respond to high-dose steroids. If successful, the trial might resolve…

Taking Lemtrada (alemtuzumab) for two years inhibited magnetic resonance imaging (MRI) disease activity in patients with relapsing-remitting multiple sclerosis (RRMS) for more than six years, the CARE-MS I clinical trial extension study found. Researchers presented their study, “Durable Efficacy of Alemtuzumab on MRI Disease Activity Over 6 Years in Treatment-Naive RRMS Patients With…

Multiple sclerosis patients who benefited from Ocrevus (ocrelizumab) in two Phase 3 clinical trials continued to benefit when they extended their treatment, researchers reported. In fact, their annual relapse rates have fallen even further during the extension study than during the trials. The study, “Preliminary Results of the OPERA I and…

Long-term treatment for up to 12o weeks, with the investigational drug Ozanimod (RPC-1063), found to be effective and safe in patients with relapsing multiple sclerosis (MS) who participated in the RADIANCE clinical trial. Celgene, Ozanimod’s developer, presented the study, “Efficacy and Safety of Ozanimod in the Blinded Extension (120…

Cladribine tablets reduced relapsing multiple sclerosis patients’ annual relapse rate by 55 to 57 percent, depending on the dose, according to clinical trials. EMD Serono, a unit of Cladribine’s developer, Merck, presented the trial results at the 31st annual meeting of the Consortium of Multiple Sclerosis Centers in New Orleans,…

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 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…

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.

Cladribine tablets reduce the risk of disability progression and relapse in patients with relapsing multiple sclerosis (MS), the CLARITY clinical trial indicates. The treatment was also well-tolerated and had a good safety profile, according to a presentation at the Annual Meeting of the American Academy of Neurology (AAN) in Boston,…

Axim Biotechnologies recently announced that its U.K. partner, Quay Pharmaceuticals, has secured licenses from the British Home Office to continue developing and importing its medical cannabinoid product MedChew Rx — a potential treatment for pain and spasticity in people with multiple sclerosis (MS), among other illnesses. MedChew Rx is a gum…

Although a Phase 2b trial of the remyelination drug candidate opicinumab (also known as anti-LINGO-1 and BIIB033) failed to meet its primary goal of improving disability in relapsing and secondary progressive multiple sclerosis (MS), researchers believe the drug did cause “fairly strong” improvements. The trial evaluated four doses of the…

Siponimod slows the progression of multiple sclerosis patients’ disability, a Phase 3 clinical trial indicates. The therapy reduced the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS) by 21 percent over three months, researchers said. At six months, the reduction was 26 percent, they said. Researchers…

An investigational treatment called ATA188 that wipes out B-cells targeting the Epstein-Barr virus (EBV) has shown promise as a multiple sclerosis treatment, a Phase 1 clinical trial involving a small patient group indicates. The trial, conducted in Australia, covered six people with primary or secondary progressive MS. B-cells are a…

It’s been less than a month since Ocrevus was approved by the FDA, and the buzz hasn’t died down. Though there is some trepidation, the MS community is incredibly excited about what the new “game-changing” medication can do for patients all across the country. Here are just a few…

Pamela Arterbridge is one of 70 people at Ohio State University’s Multiple Sclerosis Center taking part in the open-label part of a clinical trial for ocrelizumab, now best known as Ocrevus.  She is a patient of Dr. Michael Racke, who is a pioneer in the field of B-cell treatments for MS,…

Multiple Sclerosis News Today interviewed Dr. Linard Filli,
 an MS researcher at the University Hospital Zurich involved in clinical studies of prolonged release Ampyra (dalfampridine), on walking ability in MS patients, and Dr. Andrew Blight, chief scientific officer at Acorda Therapeutics, the treatment’s developer. Here is a full transcript of that interview. An…

Nektar Therapeutics has started a Phase 1 clinical trial of its biologic therapy NKTR-358 for inflammatory disorders and autoimmune diseases like multiple sclerosis. NKTR-358 is a first-in-class regulatory T-cell stimulator designed to correct the immune system dysfunction associated with these disorders. It targets regulatory T-cells, or Tregs. Other immunosuppressant therapies suppress the…

Dr. Stephen Hauser, chair of the neurology department at the University of California San Francisco, was instrumental in the early research and later clinical trials that ultimately led to Ocrevus (ocrelizumab), the first therapy approved by the U.S. Food and Drug Administration (FDA) for both relapsing MS (RMS) and primary progressive multiple sclerosis…

Here’s my Pick of the Week’s News, as published in Multiple Sclerosis News Today. National MS Society-Sponsored Group Creates Tool Set to Measure Outcomes in MS Clinical Trials Speeding up clinical trials should have the knock-on effect of shortening the whole process of developing and approving new…

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…

An extension of a Phase 3 clinical trial has shown that early treatment with Rebif (interferon beta-1a) in patients with initial manifestations of multiple sclerosis (MS) can prolong the time to a clinically definite multiple sclerosis (CDMS) diagnosis over five years. The study, “Subcutaneous interferon β-1a in…

Worldwide Clinical Trials has added two webinars to its free webinar series — the first to observe Multiple Sclerosis Awareness Month in March and the second for Parkinson’s Awareness Month in April. Although both are free, attendees need to sign up in advance (see the link below). The first informative session will take place…

Alkermes has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS). The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better than Tecfidera…

A clinical test of whether bionic robotics can improve mobility in people with relapsing or progressive forms of multiple sclerosis (MS) and considerable disability is now recruiting participants, after being approved by the U.K. National Health Service’s Health Research Authority (HRA) ethics committee. The trial, called RAPPER 3 (Robot Assisted Physiotherapy Exercises with Rex…

Australia’s Innate Immunotherapeutics confirmed that its Phase 2b clinical trial evaluating the drug MIS416 in patients with secondary progressive multiple sclerosis (SPMS) will wrap up by April 30, as scheduled, and data is expected to be release in the fall. MIS416 is a biologically derived new immune modulator that can…