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.