Multiple Sclerosis Clinical Trial

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

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).

View Eligibility Criteria

Eligibility 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 is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

35

Study ID:

NCT03126760

Recruitment Status:

Terminated

Sponsor:

Mallinckrodt ARD LLC

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There are 22 Locations for this study

See Locations Near You

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

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

35

Study ID:

NCT03126760

Recruitment Status:

Terminated

Sponsor:


Mallinckrodt ARD LLC

How clear is this clinincal trial information?

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