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

Mallinckrodt

Status and phase

Terminated

Phase 4

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: Placebo

Drug: Acthar Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT03126760

MNK14274069

Details and patient eligibility

About

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).

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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