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

A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis

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 Overview

• Status: Terminated
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Drug: Placebo; Drug: Acthar Gel

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research LLC
  • Florida
    • Bradenton, Florida, United States, 34205
      • University Of South Florida
    • Maitland, Florida, United States, 32751
      • Neurology Associates, P. A.
    • Miami, Florida, United States, 33136
      • University of Miami - Miller School of Medicine
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic, PA
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Multiple Sclerosis Center of Atlanta
    • Savannah, Georgia, United States, 31405
      • Meridian Clinical Research LLC
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Consultants in Neurology Ltd
    • Peoria, Illinois, United States, 61603
      • OSF Healthcare System Saint Francis Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute, Inc.
  • Michigan
    • Detroit, Michigan, United States, 97205
      • Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • Buffalo, New York, United States, 14215
      • University of Buffalo
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Dayton, Ohio, United States, 45417
      • University of Cincinnati Physicians Company, LLC
    • Sandusky, Ohio, United States, 44870
      • Northern Ohio Neuroscience, LLC
  • Texas
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio
  • Washington
    • Tacoma, Washington, United States, 98405
      • MultiCare Neuroscience Center of WA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 42

Collaborators and Investigators

• Sponsor: Mallinckrodt ARD LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): July 14, 2020
• Study Completion (Actual): July 14, 2020

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: RRMS; Relapsing, Remitting Multiple Sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenocorticotropic Hormone
• Other Study ID Numbers: MNK14274069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03126760) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No