Back to resultsActhar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS) (OPTIONS)
Primary Purpose
Multiple Sclerosis, Relapsing-Remitting
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acthar Gel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Relapsing, Remitting Multiple Sclerosis, RRMS
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
Sites / Locations
- Stanford University Medical Center
- Advanced Neurosciences Research LLC
- University of South Florida
- Neurology Associates, P. A.
- University of Miami - Miller School of Medicine
- Tallahassee Neurological Clinic, PA
- Multiple Sclerosis Center of Atlanta
- Meridian Clinical Research LLC
- Consultants in Neurology LTD
- OSF Healthcare System Saint Francis Medical Center
- Fort Wayne Neurological Center
- University of Kansas Medical Center Research Institute, Inc.
- Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center)
- University of New Mexico
- University of Buffalo
- Wake Forest University School of Medicine
- The Cleveland Clinic Foundation
- University of Cincinnati Physicians Company, LLC
- Northern Ohio Neuroscience, LLC
- Texas Neurology, PA
- Neurology Center of San Antonio
- MultiCare Neuroscience Center of WA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acthar Gel
Placebo
Arm Description
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
Participants receive Placebo under the skin once a day for 14 consecutive days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03126760
Brief Title
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
Acronym
OPTIONS
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties and COVID-19 logistical challenges; no safety concerns
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
July 14, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt ARD LLC
4. Oversight
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
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Relapsing, Remitting Multiple Sclerosis, RRMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acthar Gel
Arm Type
Experimental
Arm Description
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive Placebo under the skin once a day for 14 consecutive days
Intervention Type
Drug
Intervention Name(s)
Acthar Gel
Other Intervention Name(s)
Repository Corticotropin Injection
Intervention Description
Acthar Gel 1 mL (80U) for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Placebo for subcutaneous injection
Primary Outcome Measure Information:
Title
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Advanced Neurosciences Research LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
University of South Florida
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Neurology Associates, P. A.
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of Miami - Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Tallahassee Neurological Clinic, PA
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Multiple Sclerosis Center of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Meridian Clinical Research LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Consultants in Neurology LTD
City
Northbrook
State/Province
Illinois
ZIP/Postal Code
60062
Country
United States
Facility Name
OSF Healthcare System Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Kansas Medical Center Research Institute, Inc.
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
97205
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Cincinnati Physicians Company, LLC
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Northern Ohio Neuroscience, LLC
City
Sandusky
State/Province
Ohio
ZIP/Postal Code
44870
Country
United States
Facility Name
Texas Neurology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Neurology Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
MultiCare Neuroscience Center of WA
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
We'll reach out to this number within 24 hrs