Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02446886 : Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS
PhasePhase 4
AgesMin: 18 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02446886      |      Link to official Clinicaltrials.gov listing
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