SUMMARY: Investigators are recruiting 66 people with relapsing-remitting MS who have had a relapse and did not experience recovery from the relapse after high-dose intravenous or oral steroids. This study aims to determine the safety and effectiveness of H.P. Acthar Gel®
(repository corticotropin injection, Mallinckrodt Pharmaceuticals), a gel injected under the skin that is designed to provide extended release of steroids to treat acute MS relapse. The study is funded by Mallinckrodt Pharmaceuticals.
: MS relapses or exacerbations involve inflammation in the central nervous system that damages the myelin coating around nerve fibers. This damage slows or disrupts the transmission of nerve impulses and causes flare-ups of the symptoms of MS. Most relapses will gradually resolve without treatment. For severe relapses (involving loss of vision, severe weakness or poor balance, for example), which interfere with a person’s mobility, safety or overall ability to function, most neurologists recommend treatment with corticosteroids. Options for administering steroids include high-dose steroids infused into the vein or taken by mouth, and steroids delivered via the injection of a gel under the skin. This study is seeking to determine whether injection of gel (H.P. Acthar Gel) is effective in treating people with relapsing-remitting MS who do not respond to treatment of a relapse with intravenous or oral steroids.
Eligibility and Details
: Participants are people diagnosed with relapsing-remitting MS older than 18 who have had a relapse within the last 29 days and have failed to improve following treatment with high-dose intravenous or oral steroids. Further enrollment criteria are available from the contact below.
Participants are being randomly assigned to receive either H.P. Acthar Gel or inactive placebo, delivered via injection under the skin, once daily for 14 days. Follow-up visits are occurring at 14, 28 and 42 days. The primary endpoint being measured is improvement on the EDSS (a standard scale of physical disability). Other endpoints include scores on scales that measure physical impact, fatigue, quality of life, workplace productivity and use of healthcare resources.
: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Valerie Carvajal by phone at (800) 556-3314, or via email at firstname.lastname@example.org
Sites are enrolling in the following cities:
Fort Collins, Colorado
Fort Wayne, Indiana
Kansas City, Kansas
New York, New York
Round Rock, Texas
San Antonio, Texas
Salt Lake City, Utah
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill. Read more here
H.P. Acthar Gel is a registered trademark of Mallinckrodt Pharmaceuticals