Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®)
Intervention description: Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).
ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors.
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Multiple Sclerosis; MS; RRMS; SPMS; ACTH

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.
    

Eligibility 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