clinical trials

There is now less than a month until the U.S. Food and Drug Administration (FDA) is expected to approve Ocrevus, generic name ocrelizumab, for use as a therapy for multiple sclerosis. Clinical trials have shown Genentech’s drug to be a promising therapy for relapsing MS and, significantly,…

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:…

Results from a Phase 2 proof-of-concept study of ADS-5102 (amantadine HCl), showing that multiple sclerosis patients given the extended-release oral treatment improved their walking speed, will be presented at ACTRIMS 2017 this week. Findings in the poster, “A Phase 2 Study of ADS-5102 (amantadine hydrochloride) Extended Release Capsules in Multiple Sclerosis Patients with Walking Impairment,”…

A Phase 3 clinical trial evaluating the safety and effectiveness of ozanimod (RPC-1063) in patients with relapsing multiple sclerosis (RMS) shows treatment reduced the disease’s annualized relapse rate (ARR), researchers reported. The Phase 3 SUNBEAM trial (NCT02294058) tested ozanimod, an oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator designed to…

EMD Soreno has recently published Phase 3 clinical data showing that Cladribine tablets reduced the annualized rate of brain volume loss (BVL, brain atrophy) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS). The study, “Reduced brain atrophy rates are associated with lower risk of disability progression…

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…

Here’s my Pick of the Week’s News, as published by Multiple Sclerosis News Today. Clinical Trial Supports Stem Cell Transplants to Treat RMS Patients with High Disease Activity It’s no secret to readers of this column and, indeed, to the wider MS community, that I am convinced…

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…

An extension trial assessing generic glatiramer acetate (GTR) treatment in multiple sclerosis (MS) patients found that the formulation is as safe and effective as Copaxone (branded glatiramer acetate), and that switching to GTR is well-tolerated. The findings were in the study, “Switching from branded to generic glatiramer acetate:…

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…

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…

Here’s my Pick of the Week’s News as published by Multiple Sclerosis News Today. MS Patients with Spasticity Needed for Study of Extended-release Baclofen Capsules Now here’s a rare chance to get involved in a clinical trial – as long as you have MS and experience some form…

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…

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…

Australia has granted a patent to RegeneRx Biopharmaceuticals for an active ingredient in a therapy that could benefit multiple sclerosis (MS) patients. The patent is for Thymosin beta 4 (Tβ4), the driving force in the company’s RGN-352 treatment. RGN-352 promotes myelination, or the production of protective myelin sheaths for damaged neurons and other nerve…

Cyclophosphamide (CPM) may delay the progression of disability in the first years of secondary progressive multiple sclerosis (SPMS), but patients must take it for two years — and many are unlikely to tolerate it for that long. The study, “Double-Blind Controlled Randomized Trial of Cyclophosphamide versus Methylprednisolone in Secondary Progressive…

GeNeuro recently announced that it has finished enrolling multiple sclerosis (MS) patients in the CHANGE-MS Phase 2b  study — several months ahead of schedule. The company now expects to report topline results in mid- to late autumn rather than at year’s end. “Completing enrollment in CHANGE-MS several months sooner than previously anticipated…

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…

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…

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…

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…

Multiple sclerosis (MS) patients now taking part in a Phase 2b clinical trial testing the efficacy and safety of the antibody GNbAC1 will be invited to continue with treatment for two more years under a planned extension study, the biopharmaceutical companies GeNeuro and Servier recently announced. Several MS therapies rely on the capacity of antibodies to…

Data from the CARE-MS II clinical trial showed that Lemtrada (alemtuzumab) can lessen pre-existing disabilities in patients with relapsing-remitting multiple sclerosis (RRMS) who failed to respond adequately to previous disease-modifying therapies, according to a study of the trial’s data. The treatment was evaluated against Rebif (interferon beta-1a) therapy. The study, “Alemtuzumab…

AXIM Biotech has closed on a private funding round that will enable it to continue clinical trials for a variety of conditions, including its pharmaceutical candidate MedChew Rx, a patented cannabinoid release chewing gum for treating pain and spasticity in multiple sclerosis (MS). According to a press release from SECFilings.com,…