enrollment

Following promising data from the first participant in a special access program that’s testing foralumab nasal spray for secondary progressive multiple sclerosis (SPMS), a second patient has been enrolled in the ongoing evaluation. The first patient in the study, by Tiziana Life Sciences, the nasal spray’s developer, was halfway through…

ImStem Biotechnology announced that the first patient in its Phase 1 clinical trial for IMS001, an investigational treatment for multiple sclerosis (MS), has been dosed at the Shepherd Center in Atlanta. The trial (NCT04956744) is recruiting participants with an MS diagnosis ages 18 to 65. More information…

Immunic Therapeutics has enrolled the first patient in a Phase 2 clinical trial testing its oral therapy candidate IMU-838 for the treatment of progressive multiple sclerosis (MS). The trial, CALLIPER (NCT05054140), is expected to run in parallel to the company’s two identically-designed Phase 3 trials, dubbed…

Investigators are looking for people with progressive forms of multiple sclerosis (MS) to participate in two Phase 3 clinical trials assessing the safety and effectiveness of tolebrutinib (SAR442168), an oral BTK inhibitor that is being investigated as a potential treatment, the National Multiple Sclerosis Society announced…

In response to the COVID-19 pandemic, Atara Biotherapeutics has temporarily paused patient enrollment in the second and randomized part of its ongoing Phase 1 clinical trial investigating ATA188 in people with progressive forms of multiple sclerosis (MS). People treated in the first, open-label part of this trial, however,…

A new Phase 3 clinical trial to explore the safety and efficacy of Mapi Pharma’s once-a-month injectable formulation of glatiramer acetate — named GA Depot — has started enrolling patients with relapsing multiple sclerosis (MS). The trial (NCT04121221) is expected to enroll approximately 960 participants, 18 to 55…

Immunic Therapeutics announced that a Phase 2 clinical trial of IMU-838, its experimental oral therapy for relapsing-remitting multiple sclerosis (RRMS), is fully enrolled ahead of schedule. The trial, called EMPhASIS, also exceeded its target number of participants: Immunic set an initial recruitment goal of 195 patients by mid-2020, and enrolled 210…

The Phase 2 clinical trial testing BrainStorm Cell Therapeutic’s investigational NurOwn therapy for progressive multiple sclerosis (MS) has added a third clinical site, the company announced. The trial (NCT03799718) now will enroll patients at the Keck School of Medicine of The University of Southern California (USC), and its academic…

A clinical trial based at the Cleveland Clinic and the University of Nottingham, U.K., is recruiting patients with relapsing-remitting multiple sclerosis (RRMS) to compare two treatment strategies, the National Multiple Sclerosis Society announced. The Phase 4 study, called DELIVER-MS (NCT03535298), intends to enroll about 800…

TG Therapeutics announced it has reached target enrollment in the ULTIMATE I and II Phase 3 clinical trials assessing the use of ublituximab (TG-1101) to treat relapsing forms of multiple sclerosis (MS). Ublituximab is a modified anti-CD20 monoclonal antibody, which is designed to target a protein present on mature…

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…

Mallinckrodt Pharmaceuticals is seeking 66 participants for a clinical trial to determine the safety and effectiveness of its injected therapy H.P. Acthar Gel as a treatment for acute relapses in people with relapsing-remitting multiple sclerosis (RRMS). MS relapses are flare-ups of central nervous system inflammation that damage the myelin coating that protects nerve cells. The damage disrupts the transmission of impulses between the cells, causing spikes in MS symptoms. For severe relapses that interfere with a person’s mobility, safety or ability to function, most neurologists recommend corticosteroid treatment administered intravenously or taken orally. Steroids can also be administered by injection of a gel under the skin. H.P. Acthar Gel is designed to provide extended release of steroids in the body. The trial will evaluate whether the gel is an effective treatment for RRMS patients who have been unable to recover from a relapse after receiving high-dose intravenous or oral steroids. Researchers will randomly assign participants to receive either H.P. Acthar Gel or a placebo, delivered by injection once a day for 14 days. Follow-up visits will be required at 14, 28 and 42 days. The study's main objective will be seeing whether patients' disability improves. Researchers will use a standard tool for measuring disability known as the Expanded Disability Status Scale.  Other objectives will include seeing how the therapy affects patients' fatigue, quality of life, workplace productivity, and use of healthcare resources. Participants must have a confirmed diagnosis of RRMS, be older than 18 years of age, and have experienced a relapse within 29 days of enrolling in the trial. For more information about enrollment criteria and how to participate in the trial, please contact Valerie Carvajal at (800) 556-3314 or by email at [email protected]. The National Multiple Sclerosis Society announced in an MS trial alert that Mallinckrodt will be  enrolling participants in Tucson; Fort Collins, Colo.; Tampa; Atlanta; Savannah, Ga.; Northbrook, Ill.; Fort Wayne, Ind.; Indianapolis; Kansas City, Kan.; New York; Cleveland; Dayton, Ohio; Dallas; Round Rock, Texas; San Antonio; Salt Lake City; Richmond, Va.; and Tacoma, Wash. Without clinical trial participation there is no way for patients to obtain new medicines or for scientists to ultimately find a cure for MS. The National MS Society encourages participation. It has developed a guide for patients who want to take part in studies called “Participating in Clinical Trials.” It covers the basics of participation, benefits versus risks, patient protection, costs and other important issues about trials.  

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…

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…