UK-based specialist pharmaceutical firm Mallinckrodt has begun patient enrolment in the Phase IV OPTIONS clinical trial of HP Acthar gel to manage exacerbations in relapsing and remitting multiple sclerosis (RRMS) patients.
HP Acthar gel is a US Food and Drug Administration (FDA) approved injectable repository corticotrophin.
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The pilot, multi-centre, randomised, double-blind, placebo-controlled parallel group Phase IV trial is designed to evaluate HP Acthar gel’s safety and efficacy in patients with MS relapses of moderate severity and symptoms.
The trial will only include patients whose symptoms have not improved after treatment with an intravenous (IV) or oral high-dose corticosteroids, due to which the enrolment is expected to take several years for completion.
Mallinckrodt chief scientific officer and executive vice-president Steven Romano said: "Mallinckrodt is committed to providing alternative treatment options to patients who need them.
"Clinical experience and current labeling support the use of Acthar to speed recovery from relapses in MS. We are pleased to enrol the first patient in the OPTIONS trial to better understand the patients who will benefit from Acthar therapy, and to support its role in the management of RRMS."
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By GlobalDataThe trial will assess the improvement in relapse symptoms using measures such as the expanded disability status scale (EDSS), MS impact scale (MSIS-29) and clinical global impressions-improvement scale (CGI-I).
The FDA approved the gel for the treatment of 19 indications, including dieresis, remission of proteinuria in nephrotic syndrome, exacerbations in systemic lupus erythematosus and systemic dermatomyositis.
