clinical trials

Novartis is seeking U.S. and European approval of its investigational oral agent siponimod to treat adults with secondary progressive multiple sclerosis (SPMS). The U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application, while the European Medicines Agency (EMA) has accepted for review…

The Accelerated Cure Project (ACP) for Multiple Sclerosis and EMD Serono— a unit of Merck KGaA —  will jointly incorporate the perspectives of U.S. and Canadian multiple sclerosis (MS) patients into the design and implementation of clinical trials. The ACP, a nonprofit group based in Waltham, Massachusetts, strives to accelerate…

Treatment with Ocrevus (ocrelizumab) over five years lessened upper limb disability progression in primary progressive multiple sclerosis (PPMS) patients, reduced relapses and brain disease activity in patients with relapsing MS, and helped achieve no evidence of disease progression (NEDA) in a greater proportion of African-descent patients, compared to treatment…

A 48-week treatment of relapsing multiple sclerosis (MS) with TG Therapeutics’ investigational compound ublituximab led to a marked reduction of brain and spinal cord lesions, massive depletion of relapse-associated immune B-cells, and significantly halted disability progression, according to results from a Phase 2 clinical trial. The data…

MMJ International has filed two applications with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical studies testing its pharmaceutical grade cannabis-based therapies in easing symptoms associated with multiple sclerosis and Huntington’s disease. “The filing of these applications with the FDA brings us one step…

Results from a Phase 3 clinical trial show that urinary symptoms can be reduced significantly after treatment with low-dose Botox (100 units) in patients with multiple sclerosis (MS). That finding was reported in the study “Low-dose onabotulinumtoxinA improves urinary symptoms in noncatheterizing patients with MS,” published in the…

Long-term treatment with Ocrevus (ocrelizumab)  — as well as switching from Rebif (interferon beta-1a) to Ocrevus — leads to a significant and sustained reduction in disease activity in relapsing forms of multiple sclerosis (MS). These previously reported findings are further supported by the latest results drawn from pooled data…

A new clinical trial will be the first in the world to recognize the importance of retaining hand function for wheelchair-bound patients with primary progressive MS (PPMS), according to a press release from Queen Mary University of London. The international trial, which will be conducted by a…

Treatment with Ocrevus (ocrelizumab) slows disability progression in primary progressive multiple sclerosis (PPMS) in ways that may be of considerable importance to patients — including the possibility of delaying the need for a wheelchair by up to seven years, according to new data from a Phase 3…

MMJ Bioscience, which specializes in medical cannabis products, has filed a request with the U.S. Food and Drug Administration (FDA) to open Phase 2 clinical trials evaluating the company’s THC/CBD pharmaceutical compounds as possible treatments for symptoms of multiple sclerosis (MS). THC refers to the tetrahydrocannabinol compound, part of the…

Oryzon Genomics will give updates on its leading investigational product ORY-2001, a brain-targeting epigenetic therapy now in a Phase 2 clinical trial recruiting multiple sclerosis patients, at a series of scientific conferences. According to a press release, these include two conferences in the United States, the 2018 BIO…

A formulation of ofatumumab (brand name Arzerra) to be injected under the skin (subcutaneous) was found to be safe and effective in the treatment of relapsing-remitting multiple sclerosis (RRMS), even when given at lower doses…

Complications from Gilenya Treatment Managed Successfully, Case Report Says This wasn’t a minor complication. It was a version of PML, a brain disease that can be fatal. PML is also a known side effect of Tysabri, so the report of a successful treatment should be important to…

A Johns Hopkins University-initiated clinical trial is starting to enroll an estimated 900 relapsing-remitting multiple sclerosis (RRMS) patients to assess the benefits of switching therapies to prevent or reduce disability. The TREAT-MS study (NCT03500328) will evaluate whether RRMS patients with disease activity while on a traditional first-line disease-modifying therapy…

One thing we’ve all hoped for with our disease-modifying therapies (DMT) is a treatment that will improve our multiple sclerosis (MS) and not just keep it from worsening. The latest studies presented on Ocrevus (ocrelizumab) hold promise that this treatment may have finally arrived. According to recent reports,…

An additional analysis of data from the CLARITY study confirmed the long-term benefits of treatment with Mavenclad (cladribine tablets) for patients with highly active relapsing forms of multiple sclerosis (MS). The post-hoc analysis, “Efficacy of Cladribine Tablets in high disease activity subgroups of patients…

#AAN2018 – Stem Cell Transplant is Effective Treatment for ‘Aggressive’ MS, Study Shows I like the fact that a study shows that stem cell transplant treatment is effective for aggressive MS. I love the fact that the efficacy was dramatic, reducing the Expanded Disability Status Scale (EDSS) levels…

An additional analysis of data collected during the Phase 3 PARADIGMS trial found Gilenya (fingolimod) can prevent the progression of disability and control multiple sclerosis (MS) activity in pediatric patients. Results of the analysis were the subject of an oral presentation Tuesday at the 2018 American Academy of Neurology…

A one-year analysis of the ongoing Phase 3 EVOLVE-MS-1 trial of ALKS 8700 as a therapy for relapsing remitting multiple sclerosis (RRMS) supports the experimental therapy’s effectiveness, with the treatment significantly reducing the number of MS lesions. Interim results from the trial were presented Tuesday at the…

Autologous non-myeloablative hematopoietic stem cell transplant was found to be significantly better at reducing risks for disability in relapsing-remitting multiple sclerosis (RRMS) patients compared to disease-modifying drug (DMD) therapies, interim results of the MIST clinical trial show. The results will be shared at the 2018 Annual Meeting of the American…

Levels of a protein stemming from brain cell damage can mirror the severity and symptoms of multiple sclerosis, an analysis of combined data from three trials showed. Researchers will present this and related findings at the annual meeting of the American Academy of Neurology in Los Angeles, April 21-27. The…

Genentech’s Ocrevus (ocrelizumab) reduces levels of cerebrospinal fluid biomarkers that denote nerve cell damage in multiple sclerosis patients, a Phase 3 clinical trial shows. Researchers will present the results at the American Academy of Neurology’s annual meeting in Los Angeles, April 21-27. The presentation will be titled “Interim Analysis of the…

Novartis‘ siponimod (BAF312) can reduce blood levels of a biomarker of nerve cell damage in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. Researchers will present the latest results of the ongoing trial at the 2018 annual meeting of the American Academy…

Mylan and Mapi Pharma will jointly develop and commercialize Glatiramer Acetate (GA) Depot, an investigative, long-lasting formulation of the commonly used multiple sclerosis (MS) therapy Copaxone (marketed by Teva Phatmaceutical). Under the terms of the partnership, Mylan will acquire global marketing rights for the therapy. The companies are in…

Professor Frederik Barkhof, MD, PhD, has won the 2018 John Dystel Prize for Multiple Sclerosis Research for pioneering the use of magnetic resonance imaging (MRI) to improve multiple sclerosis (MS) diagnosis and understanding of the disease. The prize, decided by a peer committee, is awarded annually by…

Topline results of an exploratory Phase 2 clinical trial revealed that Flex Pharma‘s treatment candidate FLX-787 improves muscle cramps, spasms and muscle stiffness in patients with multiple sclerosis (MS). The double-blinded trial, conducted in Australia, evaluated an oral dose of 19 mg FLX-787, taken twice daily in liquid…

Blood stem cell transplants lead to significant improvements in relapsing-remitting multiple sclerosis patients’ disability, a Phase 3 clinical trial shows. The 110 patients who took part in the MIST study (NCT00273364) were having relapses after receiving standard therapies such as beta interferon, Copaxone (glatiramer acetate), Novantrone (mitoxantrone), Tysabri (natalizumab), Gilenya (fingolimod),…

AbobotulinumtoxinA, marketed as Dysport Therapeutic by Ipsen Biopharmaceuticals Canada, was approved by Health Canada for the treatment of lower limb focal spasticity in adults. Focal spasticity is a medical disorder characterized by an abnormal increase in muscular stiffness in one or more muscles, and usually is the result…

The National Multiple Sclerosis Society will award $433,800 to 10 high-risk pilot studies that will quickly evaluate new strategies and interventions and enhance knowledge about multiple sclerosis (MS). According to a press release, the award winners will address different aspects of the disease, including potential treatments for fatigue and loneliness, to improve patients' walking abilities, and a strategy to change gut bacteria effects in MS. The year-long Pilot Research Grant program is a way to support early-stage research projects to quickly test their effectiveness. The MS Society also said that additional projects will be awarded this year. Results of a recent survey of approximately 300 pilot grant recipients revealed the program successfully promotes new ideas and brings new researchers to the MS field. About 90 percent of the respondents agreed that the financial support was very important for their research project. In 85 percent of cases, the grant supported new ideas, and in 56 percent it allowed support for additional grants. These pilot grants allow researchers to obtain preliminary data so they can decide to apply for additional funding, if the project looks  promising, or to put the idea to rest.

Merck KGaA’s evobrutinib led to significant reductions in relapsing multiple sclerosis patients’ brain and spinal cord lesions, compared with a placebo, a Phase 2b clinical trial showed. Researchers measured the number of lesions at weeks 12, 16, 20 and 24. Evobrutinib, also known as M2951, is an oral inhibitor of…