Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)

• Status: Terminated
• Trial end date: 2020-07-14
• Target enrollment: 0
• Participant gender: All

Summary

This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt; Mallinckrodt ARD LLC
• Treatments: Adrenocorticotropic Hormone

Criteria

Key Inclusion Criteria:

• Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)

• Had a relapse with onset ≤42 days prior to the Baseline Visit

• Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom

• Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids

• Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit