Acthar Gel for Multiple Sclerosis That Keeps Getting Better and Worse (RRMS)
NCT ID: NCT03126760
Last Updated: 2021-07-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
35 participants
INTERVENTIONAL
2017-05-22
2020-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse
NCT02633033
Comprehensive Analysis of Relapse in Multiple Sclerosis
NCT01906684
Evaluation of the Response to Acthar Gel Therapy in Patients Who Failed Intravenous Methylprednisolone (IVMP) for MS Relapses
NCT01900093
Effects of ACTHAR on Advanced MRI Surrogate Markers of Disease Activity and on Comprehensive Immune Signature During MS Relapses
NCT03021317
Effects of Acthar on Recovery From Cognitive Relapses in MS
NCT02290444
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Acthar Gel
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
Acthar Gel
Acthar Gel 1 mL (80U) for subcutaneous injection
Placebo
Participants receive Placebo under the skin once a day for 14 consecutive days
Placebo
Placebo for subcutaneous injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acthar Gel
Acthar Gel 1 mL (80U) for subcutaneous injection
Placebo
Placebo for subcutaneous injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mallinckrodt ARD LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Team Leader
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University Medical Center
Palo Alto, California, United States
Advanced Neurosciences Research LLC
Fort Collins, Colorado, United States
University of South Florida
Bradenton, Florida, United States
Neurology Associates, P. A.
Maitland, Florida, United States
University of Miami - Miller School of Medicine
Miami, Florida, United States
Tallahassee Neurological Clinic, PA
Tallahassee, Florida, United States
Multiple Sclerosis Center of Atlanta
Atlanta, Georgia, United States
Meridian Clinical Research LLC
Savannah, Georgia, United States
Consultants in Neurology LTD
Northbrook, Illinois, United States
OSF Healthcare System Saint Francis Medical Center
Peoria, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States
Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center)
Detroit, Michigan, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Buffalo
Buffalo, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Cincinnati Physicians Company, LLC
Dayton, Ohio, United States
Northern Ohio Neuroscience, LLC
Sandusky, Ohio, United States
Texas Neurology, PA
Dallas, Texas, United States
Neurology Center of San Antonio
San Antonio, Texas, United States
MultiCare Neuroscience Center of WA
Tacoma, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MNK14274069
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.