Vanderbilt Clinical Trials

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

Purpose

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).

Condition

Multiple Sclerosis, Relapsing-Remitting

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)
Masking Description: While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.

Arm Groups

Arm	Description	Assigned Intervention
Experimental Acthar Gel	Participants receive Acthar Gel under the skin once a day for 14 consecutive days	Drug: Acthar Gel Acthar Gel 1 mL (80U) for subcutaneous injection Other names: Repository Corticotropin Injection
Placebo Comparator Placebo	Participants receive Placebo under the skin once a day for 14 consecutive days	Drug: Placebo Placebo for subcutaneous injection Other names: Matching Placebo

More Details

Status: Terminated
Sponsor: Mallinckrodt ARD LLC

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.