Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS

• Status: Terminated
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine if monthly pulse doses of a three-day course ACTH (H.P. Acthar®) is more effective at recovering myelin at 12 months, as measured by myelin water fraction (MWF), in new multiple sclerosis lesions as compared to one course of treatment.

The main secondary objective is to utilize every three month MWF measurements to determine the peak time of remyelination in new multiple sclerosis lesions when followed over the course of 12 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone; beta-Endorphin; Hormones; Melanocyte-Stimulating Hormones

Criteria

Inclusion Criteria:

• Patients with RRMS or SPMS with new contrast-enhancing lesions who will start as part of their standard of care ACTH.

Exclusion Criteria:

• Patients having received oral or IV corticosteroids within one month prior to initial scan demonstrating contrast enhancing lesion

• Patients with known or new allergy to ACTH

• Patients being treated with Natalizumab, Rituximab, and Cyclophosphamide

• Patients unwilling to have serial MRI exams

• Patients unable to undergo MRI imaging because of having an artificial heart valve, metal plate, pin, or other metallic objects in their body or is unable to complete all the MRI scans required for this study

• Patients with acute or chronic renal disease in whom administration of gadolinium may pose risk of nephrogenic systemic fibrosis

• Patients that are pregnant

• Premenopausal woman not willing to use at least one form of contraception

• Patients with a known history of diabetes mellitus

• Patients with a known history of osteoporosis or bone density values in the osteoporosis range at screening

• Progressive neurological disorder other than RRMS or SPMS

• Clinically significant cardiovascular disease, including myocardial infarct within last 6 months, unstable ischemic heart disease, congestive heart failure, or angina

• Subjects on chronic steroid therapy for treatment of MS or other systematic disease

• Subject currently has a significant medical condition (other than MS) including the following: neurological, psychiatric, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular (including uncontrolled hypertension), gastrointestinal, urological disorder, or central nervous system (CNS) infection that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study

o Note: Active medical conditions that are minor or well-controlled are not exclusionary if, in the judgment of the Primary Investigator, they do not affect risk or the subject or the study results.

• Subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator, or was planning to relocate during the study