Multiple Sclerosis Clinical Trial

Observational Registry of Acthar Gel for Participants With Multiple Sclerosis Relapse

Summary

Acthar Gel was first approved by the Food and Drug Administration in 1952.

It has been used to treat many different illnesses, including multiple sclerosis.

This study will observe how treatment with Acthar affected the daily lives of patients who suffer with relapsing/remitting MS.

It will collect information on symptoms, recovery, treatment patterns and safety outcomes.

View Full Description

Full Description

Acthar Gel (repository corticotropin injection) contains a non-bovine analogue of adrenocorticotropic hormone (ACTH) for intramuscular or subcutaneous use.

It was initially approved by the FDA in 1952 and is used for multiple indications.

This registry will evaluate the use of Acthar Gel for the treatment of MS exacerbations in the United States.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male or Female ≥ 18 years of age.
Patient has a clinically definite relapsing form of Multiple Sclerosis according to McDonald Criteria (2010 revision).
Patient with an acute MS exacerbation as determined by their treating clinician.
Patient planning to initiate Acthar Gel for the treatment of an acute MS exacerbation.
Patient capable of providing informed consent.

Exclusion Criteria:

Patients with a diagnosis of Progressive MS.
Patients that require concomitant corticosteroid therapy.
Patients receiving experimental drug therapy.
Patients with a history of scleroderma, systemic fungal infections, ocular herpes simplex within prior 5 years.
Patient has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Enrollment Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix.
Patients who had recent surgery or have a history of or the presence of a peptic ulcer within 6 months prior to study entry, congestive heart failure, or sensitivity to proteins of porcine origin.
If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use appropriate birth control.

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

160

Study ID:

NCT02633033

Recruitment Status:

Completed

Sponsor:

Mallinckrodt

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There are 38 Locations for this study

See Locations Near You

Alabama Neurology Associates
Homewood Alabama, 35209, United States
Territory Neurology & Research Institute
Tucson Arizona, 85704, United States
Colorado Springs Neurological Associates
Colorado Springs Colorado, 80907, United States
Advanced Neurosciences Research
Fort Collins Colorado, 80528, United States
Associated Neurologists of Southern Connecticut
Fairfield Connecticut, 06824, United States
MedStar Health
Washington District of Columbia, 20007, United States
Emery Neuroscience Center
Lighthouse Point Florida, 33064, United States
Neurology Associates
Maitland Florida, 32751, United States
Cordova Research Institute
Miami Florida, 33155, United States
Collier Neurologic Specialists
Naples Florida, 34102, United States
Florida Neurological Center
Ocala Florida, 34471, United States
Neurological Services of Orlando
Orlando Florida, 32806, United States
Neurology Associates of Ormond Beach
Ormond Beach Florida, 32174, United States
Negroski, Sutherland and Hanes Neurology
Sarasota Florida, 34239, United States
Infinity Clinical Research
Sunrise Florida, 33351, United States
Columbus Research & Wellness Institute
Columbus Georgia, 31904, United States
Neurology of Central Georgia
Macon Georgia, 31210, United States
Meridian Clinical Research
Savannah Georgia, 31406, United States
College Park Family Care Center
Overland Park Kansas, 66212, United States
University System of Maryland
Baltimore Maryland, 21201, United States
International Neurorehabilitation Institute
Lutherville Maryland, 21093, United States
Neurology Center of New England
Foxboro Massachusetts, 02035, United States
Milford Regional Medical Center
Hopedale Massachusetts, 01747, United States
Detroit Clinical Research Center
Farmington Hills Michigan, 48334, United States
CentraState Medical Center
Freehold New Jersey, 07728, United States
Strotira, Inc.
New York New York, 11714, United States
Alpha Neurology
Staten Island New York, 10306, United States
Five Towns Neurology
Woodmere New York, 11598, United States
Braunstein Neurology
Mooresville North Carolina, 28117, United States
The Toledo Clinic
Toledo Ohio, 43623, United States
Oak Clinic for Multiple Sclerosis
Uniontown Ohio, 44685, United States
Optimum Neurology
Bala-Cynwyd Pennsylvania, 19004, United States
Irene Greenhouse MD
Jamison Pennsylvania, 18929, United States
Neurology and Stroke Associates
Lititz Pennsylvania, 17543, United States
D. Gary Kolva, MD, Neurology
West Reading Pennsylvania, 19610, United States
Colonial Healthcare
Sumter South Carolina, 29150, United States
Ogden Clinic
Ogden Utah, 84403, United States
Dominion Neurological Services
Richmond Virginia, 23226, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

160

Study ID:

NCT02633033

Recruitment Status:

Completed

Sponsor:


Mallinckrodt

How clear is this clinincal trial information?

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