News Trial to Evaluate H.P. Acthar Gel Is Enrolling Patients with Relapsing-remitting MS Trial to Evaluate H.P. Acthar Gel Is Enrolling Patients with Relapsing-remitting MS by Patricia Silva, PhD | January 17, 2018 Share this article: Share article via email Copy article link Mallinckrodt PharmaceuticalsĀ is seeking 66 participants for a clinical trial to determine the safety and effectiveness of its injected therapyĀ H.P. Acthar GelĀ 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 personās 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.Ā 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 emailĀ atĀ [email protected]. The National Multiple Sclerosis Society announced in an MS trial alertĀ that Mallinckrodt will be Ā 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 āParticipating in Clinical Trials.ā It covers the basics of participation, benefits versus risks, patient protection, costs and other important issues about trials. Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags clinical trials, enrollment, Mallinckrodt Pharmaceuticals, RRMS, steroids
May 7, 2024 News by Margarida Maia, PhD Wayne State professor wins grant to study oligodendrocytes in MS
May 6, 2024 News by Marisa Wexler, MS Nearly $650k awarded to advance potential remyelination drug IFB-048