clinical trial

A multiple sclerosis (MS) trial now underway in Colorado is assessing the safety and tolerability of switching from Rituxan (rituximab) to Ocrevus (ocrelizumab), and its lead investigator, Dr. Timothy L. Vollmer, largely expects no problems. The neurologist believes the two Genentech therapies — both antibody-based drugs that target the CD20 molecule on B-cells —…

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,…

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…

Pamela Arterbridge noticed something was wrong back in 2013 when she woke up one morning, and her legs and feet were tingling. Two years later, Lorraine Lee knew she had a problem when her right leg became extremely fatigued after every workout. Neither realized their eventual diagnosis would be multiple…

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…

A real-world study of Gilenya (fingolimod) in relapsing multiple sclerosis (MS) confirms benefits of the treatment seen in clinical trials. The Novartis-sponsored study also demonstrated that measures of brain shrinkage can be used in a clinical setting to evaluate disease progression. The data, presented at the American Academy of…

Texas firefighter Wayne Donovan is among the estimated 250,000 to 350,000 Americans with multiple sclerosis (MS). He enrolled in a clinical trial testing Ocrevus (ocrelizumab), which the  U.S. Food and Drug Administration recently approved as the first therapy for both relapsing and primary progressive forms of MS. Donovan was diagnosed in 2011 at…

Ampyra (dalfampridine) shows long-term efficacy in improving walking ability in people with multiple sclerosis, according to a study evaluating the treatment’s use in progressive and relapsing MS patients over two years. The study, “Monitoring long-term efficacy of fampridine in gait-impaired patients with multiple sclerosis,” was published in the…

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…

At long last, and for the first time in medical history, people with both relapsing and primary progressive forms of multiple sclerosis have reason to celebrate. The U.S. Food and Drug Administration (FDA) today approved Ocrevus (ocrelizumab)  as a disease-modifying therapy for both forms of MS, a chronic autoimmune disease.

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…

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…

Genentech’s Ocrevus (ocrelizumab) increased the proportion of patients with no evidence of progression (NEP) in the recently concluded ORATORIO Phase 3 clinical trial in patients with primary progressive multiple sclerosis (PPMS). The evaluation of NEP — a combined measure of three disability assessments — was a secondary exploratory endpoint of…

Treatment with Apitope’s lead agent, ATX-MS-1467, decreased brain lesions in patients with relapsing multiple sclerosis (MS) in a now-completed Phase 2a clinical trial. ATX-MS-1467 is a potential disease-modifying agent with an immune-tolerating action. It consists of four short peptides derived from the myelin basic protein, and is designed to reduce…

Treatment with a compound called BIIB074 shows promise in reducing pain caused by trigeminal neuralgia — a  condition that occasionally affects multiple sclerosis (MS) patients — with few side effects, a new clinical trial finds. The Swiss study, “Safety and efficacy of a Nav1.7 selective sodium channel blocker in Titrigeminal neuralgia:…

A specialty shoe insole that may help multiple sclerosis (MS) patients walk and go about their daily lives with more assurance and ease was developed by an Australian-led research team, which is now seeking 176 patients to test the insole in a three-month trial. The study is led by Anna Hatton, a physiotherapy professor…

A newly concluded clinical trial gives scientific evidence of the benefits that a stem cell transplant holds for multiple sclerosis (MS) patients who fail to respond to medications — with researchers calling the procedure a reasonable option for those with high disease activity. Five years after the treatment — high-dose immunosuppressive therapy followed by autologous hematopoietic cell transplant — further disease…

Continuous treatment with Gilenya (fingolimod) helps limit relapses and detectable lesions in multiple sclerosis (MS) patients, according to a three-year, follow-up study in Japan. The results confirm the findings of trials conducted in predominantly Caucasian populations. The findings were reported in the study, “Long-term efficacy and safety of fingolimod in…

More relapsing multiple sclerosis (MS) patients treated with Zinbryta (daclizumab) said they felt its health benefits than did those given Avonex (interferon beta-1a) — demonstrating that patient-reported outcomes do mirror objective measures of improved health in a clinical trial of the two drugs. Patient-reported changes in both physical and psychological health contribute to a more comprehensive picture of…

Flex Pharma said it plans to prioritize developing its clinical programs in neurological diseases, including multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and peripheral neuropathies like Charcot-Marie Tooth (CMT). One or two proof-of-concept, Phase 2 clinical trials are planned for this year in the United States to evaluate Flex Pharma’s…

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…

Family members of multiple sclerosis (MS) patients who are asymptomatic but at a higher risk of developing the disease themselves are more likely to have early signs of the disease, according to a study published in JAMA Neurology and titled "Assessment of Early Evidence of Multiple Sclerosis in a Prospective Study of Asymptomatic High-Risk Family Members". These people should therefore be closely monitored.

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…

Early data from TG Therapeutics’ Phase 2 trial of its B-cell-targeting experimental multiple sclerosis (MS) treatment ublituximab (TG-1101), showed that the drug is well-tolerated and effectively reduces B-cells in the blood. MS therapies that deplete B-cells have been effective in relapsing and progressive forms of MS. Like other B-cell-targeting drugs in…

Ibudilast (MN-166) has shown enough promise as a treatment for progressive multiple sclerosis (MS) that its U.S. Phase 2b trial (NCT01982942) should continue, the U.S. National Institute of Health’s Data and Safety Monitoring Board has recommended. A key goal of the 96-week trial is to determine whether ibudilast can slow the…

Genentech is recruiting U.S. participants for a Phase 3 study (NCT02637856) of Ocrevus (ocrelizumab) in people with relapsing-remitting multiple sclerosis (RRMS) who were not helped by previous disease-modifying therapies, according to a press release from the National Multiple Sclerosis Society. The trial is an open-label study, meaning…

Promising data from a small Phase 2a clinical trial sponsored by RedHill Biopharma for an antibiotic designed to fight certain infections suggests that adding the drug candidate to interferon treatment reduced relapse rates and brain lesion formation in patients with relapsing forms of multiple sclerosis (MS). This novel treatment approach was based on…