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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03126760
• Other study ID #: MNK14274069
• Status: Terminated
• Phase: Phase 4
• Start date: May 22, 2017
• Est. completion date: July 14, 2020

Study information

• Verified date: June 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Acthar Gel
Acthar Gel 1 mL (80U) for subcutaneous injection
• Placebo
Placebo for subcutaneous injection

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Multiple Sclerosis Center of Atlanta	Atlanta	Georgia
United States	University of South Florida	Bradenton	Florida
United States	University of Buffalo	Buffalo	New York
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Texas Neurology, PA	Dallas	Texas
United States	University of Cincinnati Physicians Company, LLC	Dayton	Ohio
United States	Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center)	Detroit	Michigan
United States	Advanced Neurosciences Research LLC	Fort Collins	Colorado
United States	Fort Wayne Neurological Center	Fort Wayne	Indiana
United States	University of Kansas Medical Center Research Institute, Inc.	Kansas City	Kansas
United States	Neurology Associates, P. A.	Maitland	Florida
United States	University of Miami - Miller School of Medicine	Miami	Florida
United States	Consultants in Neurology LTD	Northbrook	Illinois
United States	Stanford University Medical Center	Palo Alto	California
United States	OSF Healthcare System Saint Francis Medical Center	Peoria	Illinois
United States	Neurology Center of San Antonio	San Antonio	Texas
United States	Northern Ohio Neuroscience, LLC	Sandusky	Ohio
United States	Meridian Clinical Research LLC	Savannah	Georgia
United States	MultiCare Neuroscience Center of WA	Tacoma	Washington
United States	Tallahassee Neurological Clinic, PA	Tallahassee	Florida
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt ARD LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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