Study Stopped
Recruitment difficulties and COVID-19 logistical challenges; no safety concerns
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
1 other identifier
interventional
35
1 country
22
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2017
Typical duration for phase_4
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedStudy Start
First participant enrolled
May 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2020
CompletedResults Posted
Study results publicly available
June 3, 2021
CompletedJuly 12, 2021
June 1, 2021
3.1 years
April 4, 2017
May 10, 2021
June 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Acthar Gel
EXPERIMENTALParticipants receive Acthar Gel under the skin once a day for 14 consecutive days
Placebo
PLACEBO COMPARATORParticipants receive Placebo under the skin once a day for 14 consecutive days
Interventions
Acthar Gel 1 mL (80U) for subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early by sponsor decision because of recruitment difficulties and the impact of the COVID-19 pandemic. The planned analyses did not change except that the total sample size was reduced. Inferential statistics were not performed. Results are nominal because the sample size did not reach that specified in the protocol.
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt
Study Officials
- STUDY DIRECTOR
Clinical Team Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2017
First Posted
April 24, 2017
Study Start
May 22, 2017
Primary Completion
July 14, 2020
Study Completion
July 14, 2020
Last Updated
July 12, 2021
Results First Posted
June 3, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
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.