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

Phase 4TerminatedNCT03126760

Mallinckrodt ARD LLC35 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Acthar GelDRUG

Acthar Gel 1 mL (80U) for subcutaneous injection

PlaceboDRUG

Placebo for subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Stanford University Medical Center

Palo Alto, California, United States

Outcomes

Primary Outcomes

Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42

The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.

Time frame: Baseline, Day 42

Data from ClinicalTrials.gov

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