Clinical trial NCT03126760: Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Relapsing, Remitting Multiple Sclerosis
RRMS
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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

Primary outcomes:
measure: Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
timeFrame: Baseline, Day 42
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research LLC
state: Colorado
city: Bradenton
country: United States
facility: University of South Florida
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, P. A.
state: Florida
city: Miami
country: United States
facility: University of Miami - Miller School of Medicine
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic, PA
state: Florida
city: Atlanta
country: United States
facility: Multiple Sclerosis Center of Atlanta
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research LLC
state: Georgia
city: Northbrook
country: United States
facility: Consultants in Neurology LTD
state: Illinois
city: Peoria
country: United States
facility: OSF Healthcare System Saint Francis Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute, Inc.
state: Kansas
city: Detroit
country: United States
facility: Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center)
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Dayton
country: United States
facility: University of Cincinnati Physicians Company, LLC
state: Ohio
city: Sandusky
country: United States
facility: Northern Ohio Neuroscience, LLC
state: Ohio
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Tacoma
country: United States
facility: MultiCare Neuroscience Center of WA
state: Washington
Study officials:
affiliation: Mallinckrodt
name: Clinical Team Leader
role: STUDY_DIRECTOR
References: