clinical trials

Aubagio taken as 14 milligram (mg) tablet once daily significantly reduces the risk of relapse in people with relapsing multiple sclerosis (MS) over time irrespective of their prior treatment history, a pooled analysis of Phase 2 and Phase 3 trial results show. The findings were presented at the 2019…

Patients with relapsing-remitting multiple sclerosis (RRMS) who switched to infusions with Sanofi Genzyme’s Lemtrada (alemtuzumab) report increased satisfaction with treatment and improvements in health-related quality of life, according to…

Oral treatment with ozanimod (RPC1063), an investigational immunomodulator under development by Celgene, is better at preventing brain volume loss, compared with Avonex (interferon-beta-1a), in adults with relapsing forms of…

Adamas Pharmaceuticals announced the study design and baseline characteristics of patients enrolling in the company’s ongoing Phase 3 trial testing the efficacy and safety of ADS-5102 (amantadine) extended-release capsules in patients with multiple sclerosis (MS) who have difficulty walking. The data were presented in a poster,…

Treatment with Mayzent (siponimod) provided sustained improvements and prevented deterioration of cognitive processing speed in patients with secondary progressive multiple sclerosis (SPMS), regardless of their cognitive function prior to therapy, according to results of a Phase 3 clinical trial. The data were presented at the recent 2019 American…

Treatment with Tysabri (natalizumab) lowers the levels of the biomarker serum neurofilament light chain (sNfL) in patients with secondary progressive multiple sclerosis (SPMS), according to data from a Phase 3 trial. Findings also revealed that higher levels of sNfL correlated with MS lesions and disease activity prior to starting the…

High levels of satisfaction with the efficacy and convenience of Aubagio (teriflunomide), an oral treatment for relapsing multiple sclerosis (MS), were reported by patients across the U.S. and 13 other countries, a post-hoc analysis of data from a real-world Phase 4 study found. The study “Teriflunomide real-world evidence: Global…

A collaboration between DNAnexus, the Sutter Health network, and the University Pittsburgh Medical Center (UPMC) aims to improve personalized medicine in multiple sclerosis (MS) through the first large-scale clinical genomic research study, the companies announced. The network has the goal of improving screening, diagnosis, and treatment of…

A clinical trial testing a computer program called Deprexis as a home-based therapeutic strategy for multiple sclerosis (MS)-related depression is enrolling participants with all types of MS  at three sites in the U.S. and two in Germany. The U.S. study locations are the Cedars-Sinai Medical Center,…

Treatment with oral ibudilast slows brain shrinkage in patients with primary progressive multiple sclerosis (PPMS), but not in those with secondary progressive MS (SPMS), according to results of a Phase 2b clinical trial. According to the findings, this could be partially due to faster disease progression in untreated…

Phase 3 Trial of ADS-5102 Recruiting Participants of All MS Types This medication is similar to Ampyra (dalfampridine) because its goal is to improve walking in those with MS. It sure would be nice if we had another medication approved that could do that. Though this trial began recruiting…

A Phase 3 trial testing ADS-5102 (amantadine) extended release capsules in all types of multiple sclerosis (MS) is enrolling participants to determine whether the oral therapy can improve walking speed. A total of 570 adults with MS, ages 18 to 70 years, who have difficulty walking will be…

The first patient has been enrolled in a Phase 2 multicenter clinical trial testing the use of NurOwn cellular therapy to treat progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics announced. The open-label trial (NCT03799718), titled Safety and Efficacy of Repeated Administration of neuron (MSC-NTF Cells) nin Participants…

Two-year treatment with temelimab reduced brain atrophy, or shrinkage, preserved myelin, and reduced disease progression in patients with relapsing-remitting multiple sclerosis (RRMS), according to findings from an extension study of a Phase 2b clinical trial. Temelimab, previously known as GNbAC1, is a monoclonal antibody that neutralizes the MS-associated human…

The Cleveland Clinic Nevada is recruiting participants for DELIVER-MS, a clinical trial comparing two common treatment approaches for relapsing-remitting multiple sclerosis (RRMS). Results from the DELIVER-MS trial, titled “Determining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis” (…

Treatment with ublituximab continues to be safe and well-tolerated by patients with relapsing forms of multiple sclerosis, according to an extension study of a Phase 2 trial. According to a press release, Edward Fox, MD, PhD, from Central Texas Neurology Consultants, will give the presentation on May 7 at poster session P3: MS Clinical Trials and Therapeutic Research. Ublituximab is an investigational monoclonal antibody being developed by TG Therapeutics to target the immune B-cell marker protein CD20. This leads to the depletion of B-cells from the blood and central nervous system — B-cells are activated during MS relapses. According to the company, ublituximab may be superior to current anti-CD20 treatments in MS, enabling both lower doses and shorter infusion times. Final results of the main TG-Therapeutics-sponsored Phase 2 trial were recently presented at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held in Dallas, Texas. Data showed that 93% of the 48 patients enrolled (mean age 40 years) were relapse-free after a 48-week treatment with ublituximab. The annualized relapse rate — the number of relapses per year — was 0.07. In addition, median B-cell depletion was more than 99% throughout 48 weeks. Moreover, 87% of participants showed no evidence of clinical disease. Magnetic resonance imaging showed a complete elimination of T1 lesions at 24 and 48 weeks 24 in all 46 patients analyzed. Mean T2 lesion volume decreased by 10.6% at 48 weeks, compared with the beginning of the study. T1 lesions refer to areas of active inflammation and disease activity, while T2 lesions are a measure of the total amount of lesions, both old and new. Ublituximab was found to be well-tolerated, and did not induce an severe treatment-related adverse events. The most frequent adverse events were infusion-related reactions. No patient had to discontinue treatment due to an ublituximab-related side effect. At the upcoming AAN meeting, Fox will present data on both this Phase 2 trial and its open-label extension, in which 37 patients from the primary study continued receiving one-hour infusions of 450 mg of ublituximab every 24 weeks for an additional 96 weeks. Safety was monitored throughout the study, and disability assessments using the Expanded Disability Status Scale were conducted every 48 weeks. As of October 2018, nearly 30% of participants had completed 48 weeks of treatment in the extension study. Results showed that ublituximab continues to be well-tolerated, with no discontinuations due to adverse events. “The Phase 2 OLE supports that one-hour infusions of [ublituximab] continue to be safe and well tolerated,” the researchers wrote. Of note, five of the eight study authors are affiliated with TG Therapeutics. The team expects additional patient follow-up data from the study to be available by the time of the AAN presentation. According to the scientists, the results support the ongoing Phase 3 ULTIMATE program, which includes the ULTIMATE 1 and ULTIMATE 2 trials. These studies are comparing the efficacy and safety of 450 mg of ublituximab with Aubagio over 96 weeks of treatment in relapsing MS patients. Both trials are led by Lawrence Steinman, MD, at Stanford University. TG Therapeutics expects to have results from these trials as early as mid-2020.

The National Multiple Sclerosis Society is funding a new Phase 2 clinical trial to test the effectiveness of stem cell therapy on individuals with progressive forms of multiple sclerosis (MS), using mesenchymal stem cells from their own bone marrow. The ability of stem cells to both self-renew and create…

Immunic Therapeutics has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy for relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role…

A daily cup of flavonoid-rich cocoa may help ease fatigue in people with relapsing-remitting multiple sclerosis (RRMS), according to the results of a small clinical trial. The study “A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis” was…

Full results of a Phase 2 clinical trial testing TG Therapeutics’ lead candidate ublituximab (TG-1101) for relapsing multiple sclerosis (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…

Evobrutinib, Merck KGaA’s oral candidate for relapsing multiple sclerosis (MS), is safe and can significantly reduce active brain lesions over 24 weeks of treatment, results of ongoing Phase 2 study show. Xavier Montalban, PhD, MD, with Vall d’Hebron University Hospital in Barcelona, presented the results in the talk “Primary…

Stable patients with multiple sclerosis (MS) who transition from Tysabri (natalizumab) treatment to Aubagio (teriflunomide) have a lower relapse risk, a new study shows. The study, “Reducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy,”…

BrainStorm Cell Therapeutics announced the Cleveland Clinic is the first clinical site contracted in the United States for the Phase 2 multi-center study evaluating the company’s NurOwn mesenchymal stem cell (MSC) therapy in individuals with progressive multiple sclerosis (MS). “We are very excited to announce The Mellen Center for…

Aubagio (teriflunomide) seems to be superior to Tecfidera (dimethyl fumarate) in slowing whole brain shrinkage in patients with relapsing multiple sclerosis (MS), a new Phase 4 clinical trial shows. However, Aubagio and Tecfidera have similar beneficial effects in achieving other clinical goals and magnetic resonance imaging (MRI) parameters,…

A clinical trial to test the effects of antioxidant treatment with lipoic acid on progressive forms of multiple sclerosis (MS) is recruiting 118 participants at seven sites in North America. The study sites include: Birmingham, Alabama; Burlington, Vermont;  Portland, Oregon; Salt Lake City, Utah; Seattle, Washington; Washington, D.C., and;…

Rehabilitation using traditional dysphagia therapy improved swallowing function in multiple sclerosis patients with dysphagia, a pilot study shows. The research article with that finding, “The effect of traditional dysphagia therapy on the swallowing function in patients with Multiple Sclerosis: A pilot double-blinded randomized controlled trial” was…

MS Patients Sought to Test Alternative Chronic Pain Treatment Methods Do you have serious pain issues along with your MS? If so, you might be interested in this study that’s looking for participants. By the way, who says that pain isn’t an MS symptom? A clinical trial…

A clinical trial funded by the National Multiple Sclerosis Society is recruiting adult patients with multiple sclerosis (MS) to test two non-pharmacological strategies to manage MS-related chronic pain. The trial (NCT03782246) will be conducted at the University of Washington, and plans to enroll about 250 participants across…

GeNeuro has reported positive data from a Phase 1 clinical trial (NCT03574428) evaluating the safety and tolerability of high doses of GNbAC1, developed for the treatment of neurological and autoimmune disorders, including multiple sclerosis (MS). The company also announced that the World Health…

Autologous hematopoietic stem cell transplant is better than disease-modifying therapies (DMT) at reducing the risk of disease progression in patients with relapsing-remitting multiple sclerosis (RRMS), results from the MIST clinical trial show. The study “Effect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression…