clinical trials

Results from the extension period of a Phase 2 trial, assessing ozanimod as a potential treatment for relapsing-remitting multiple sclerosis, showed that the drug can effectively and safely improve clinical measures of RRMS after two years of treatment. The announcement was made by Celgene International Sàrl, a subsidiary of Celgene Corporation,…

The U.S. Department of Health and Human Services (HHS) recently announced policy changes designed to make information about clinical trials of investigational drugs, biologics and products more widely available to the public, issuing amended rules that specify the requirements for registering clinical trials and for submitting summary results to its ClinicalTrials.gov website. The…

A presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress gave patients with progressive multiple sclerosis (MS) a reason for optimism, as Novartis reported that siponimod (BAF312) reduced the risk of disability progression in a Phase 3 study of patients with secondary progressive (SP) MS.

Autoimmune side effects during five years of Lemtrada (alemtuzumab) treatment were generally not serious and mainly affected the thyroid, according to an analysis of patients in three large, Phase 3 clinical trials of the therapy. The data were presented at the Free Communications 1 session of the European Committee…

Novartis recently announced positive results from the ACROSS study, which is assessing the clinical effect of Gilenya (fingolimod) in 10-year disability outcomes in people with relapsing-remitting multiple sclerosis (RRMS). The results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Sept. 14-17 in London. The ACROSS study…

GeNeuro announced that it has reached — more quickly than expected — the halfway mark for patient enrollment in its Phase 2b study, CHANGE-MS, assessing GNbAC1 as a therapy for relapsing-remitting multiple sclerosis (RRMS). Patient recruitment is continuing at sites across Europe. The company also reported on the trial’s design in a poster presentation, “A placebo…

Merck recently presented new efficacy data from its three Phase 3 clinical trials, showing that a relatively short course of treatment with Cladribine tablets led to long-term reductions in annualized relapse rate (ARR) in people with relapsing multiple sclerosis (RMS). The data were given in two oral presentation at the 32nd Congress of the…

Leustatin (cladribine) tablets, an investigational drug, were shown to be effective at reducing annual relapse rates, not only in MS patients, but also in patients with a first demyelinating event who later converted to a clinically defined multiple sclerosis diagnosis. The results were shared in a presentation titled “Cladribine tablets in the ORACLE-MS…

Positive new data from Phase 3 clinical trials assessing Ocrevus (ocrelizumab) as a treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) were recently announced by Roche, the company responsible for marketing and developing this investigational therapy. The results are being presented at the 32nd Congress of the…

The importance of getting a representative group of people, also known as subjects, engaged in  clinical trials cannot be understated. There is so much that we need to know when it comes to multiple sclerosis, but the picture cannot be complete unless the cohort of subjects includes people from…

Patients with secondary progressive multiple sclerosis (SPMS) who were treated with BAF312 (siponimod), a sphingosine-1-phosphate (S1P) inhibitor, in a Phase 3 clinical trial showed a  significantly reduced risk for disability progression compared to placebo, Novartis recently announced. BAF312 is a selective modulator of specific types of the S1P receptor. This receptor is…

The National Multiple Sclerosis Society  announced that it has dedicated more than $1 million to support a clinical study at the University of Iowa that will compare two types of diet and their effectiveness in easing fatigue in people with multiple sclerosis (MS). “The National MS Society is committed to identifying wellness solutions to…

Relapsing multiple sclerosis patients who begin taking Betaferon/Betaseron (interferon beta-1b) immediately after the first MS-related neurologic symptoms appear may realize slower disease progression than those who delay treatment, according to a study evaluating the therapy’s effects over a decade in patients enrolled in a Phase 3 clinical trial. The study, “The 11-year long-term follow-up…

There are several key questions that a participant will want answered before enrolling in a clinical trial. Many are listed here, but patients should feel free to ask study coordinators any additional questions they may have so their concerns are well addressed before the trial starts. It is important for a study participant to learn as…

The Patient-Centered Outcomes Research Institute (PCORI) recently awarded a sum of $5.5 million to two researchers at the University of California, San Francisco (UCSF). Bardia Nourbakhsh, MD. (Credit: UCSF) Bardia Nourbakhsh, MD, a clinical fellow in Neurology, received a $2 million grant to conduct a randomized, double-blind, placebo-controlled clinical trial to…

This idea is so simple. But it has been overlooked for years until the partners of Gray Consulting, a Philadelphia firm, connected the dots and developed a better way to engage and retain people in clinical trials.  Scott Gray, CEO, took time out to speak with me about…

RedHill Biopharma announced that the final patient has completed the last step of its Phase 2 clinical study (CEASE-MS) of RHB-104 as a potential treatment for people with relapsing-remitting multiple sclerosis (RRMS). RHB-104 is an antibiotic oral medication that blocks inflammation in addition to killing bacteria. RHB-104 was originally developed as a treatment for…

A study analyzing results from three Phase 3 clinical trials shows that Gilenya (fingolimod) effectively prevents relapses in different types of relapsing multiple sclerosis (MS) patients, with the therapy being most efficient in younger patients and those without previous treatment. The findings highlight the importance of starting treatment early, and not…

In addition to a new study sponsored by Genentech to test the experimental MS therapy Ocrevus (ocrelizumab) in RMS patients who have had a sub-optimal response to previous disease modifying therapies, the company is also currently recruiting patients with relapsing multiple sclerosis to understand the therapy’s mechanism of action and B-cell biology…

A Phase 3 clinical trial exploring Ocrevus (ocrelizumab) in patients with relapsing-remitting multiple sclerosis (RRMS) is now recruiting participants. The trial, sponsored by Genentech (NCT02637856), is seeking patients who have previously taken a disease-modifying treatment that did not adequately control their disease activity. Participants must be between 18 and 55…

Patients with relapsing multiple sclerosis (MS) are being recruited for a clinical trial evaluating an experimental monoclonal antibody called ublituximab, the National MS Society announced in a recent news release. The study, being conducted at seven U.S. sites, will enroll at least 24 patients, but this number can go up to 100. MS is considered to be…

MediciNova recently reported that half of the 255 patients enrolled in a Phase 2b clinical trial (SPRINT-MS) exploring MN-166 (ibudilast) in progressive multiple sclerosis (MS) had completed the 96-week-long treatment. Interim data will be analyzed by the trial’s external Data Safety Monitoring Board later this year, with results…

MediciNova recently reported that half of the 255 patients enrolled in a Phase 2b clinical trial (SPRINT-MS) exploring MN-166 (ibudilast) in progressive multiple sclerosis (MS) had completed the 96-week-long treatment. Interim data will be analyzed by the trial’s external Data Safety Monitoring Board later this year, with results…

We wait in anticipation for multiple sclerosis (MS) drugs to clear Phase 3 clinical trials and get to the Food and Drug Administration (FDA) for approval, but I honesty knew little of the process that takes place before the large-scale testing of drugs in Phase 3. I was selected to…

This chewing gum handout in the exhibit area of the recent Drug Information Association (DIA) 2016 meeting says it all from the pharmaceutical company perspective – recruiting patients for their studies is often a distasteful and difficult process. While I appreciated the gum in this package, this image left a…

A pilot study in patients with progressive multiple sclerosis (MS) found a steroid treatment of benefit by decreasing oxidative stress in the cerebrospinal fluid. The study, “One-time intrathecal triamcinolone acetonide application alters the redox potential in cerebrospinal fluid of progressive multiple sclerosis patients: a pilot study,” was published in the journal …

Developments of treatments for MS dominate my pick of the week’s news in MS News Today. Included is a vaccine and a new oral drug. Vaccine to Treat Multiple Sclerosis Showing Promise and Soon to Enter Phase 3 Clinical Testing This is something a bit different because, usually vaccines are designed to…

Coherus BioSciences recently reported that its candidate therapy for multiple sclerosis (MS), CHS-131, reduced the development rate of new brain lesions by nearly 50% in previously untreated relapsing-remitting MS patients. The Phase 2b trial (NCT02638038), randomizing patients to receive either CHS-131 or placebo in a double-blind manner, also showed the…

A therapeutic vaccine for patients with multiple sclerosis (MS), called Xemys, is showing positive results in pre-clinical and clinical trials, and is soon to enter Phase 3 clinical testing. Xemys was developed by researchers at the Institute of Bioorganic Chemistry of the Russian Academy of Sciences and their colleagues. While traditional vaccines are…

Flex Pharma, Inc., announced the start of a Phase 2 clinical trial assessing the safety and efficacy of FLX-787 in multiple sclerosis (MS) patients who suffer from cramps, spasms, and/or spasticity as a result of the disease. The trial is being run in conjunction with Neuroscience Trials Australia. Flex Pharma’s FLX-787 is a single molecule,…