Last updated on March 2019

Pilot Study to Assess the Efficacy & Safety of H.P. Acthar Gel in Subjects With Relapsing-remitting Multiple Sclerosis

Brief description of study

This is a multicenter, multiple dose study to estimate the response rate, and examine the safety of H.P. Acthar Gel (Acthar) in subjects with RRMS who have not responded to high dose steroids. Approximately 66 subjects will be randomized.

Detailed Study Description

Subjects with RRMS who have experienced a relapse and who will receive 3 to 5 (given over a period of up to 7 days) days of treatment with high dose steroids (oral or IV) within 14 days of the onset of relapse symptoms are candidates for the current study. At 14 ( 1) days following the initiation of high dose steroids, subjects will be re-assessed with the Expanded Disability Status Scale/Functional Systems Score (EDSS/FSS) and subjects who do not improve by at least 1 point on the FSS will be randomized on a 1:1 basis to receive subcutaneous (SC) Acthar 1 mL (80 U) once a day (QD) or SC matching placebo 1 mL QD for 14 days. Follow-up visits then occur at 14, 28 and 42 days.

Clinical Study Identifier: NCT03126760

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VCU Medical Center

Richmond, VA United States
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Recruitment Status: Open

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