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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02446886
• Date of registration: 07/05/2015
• Prospective Registration: Yes
• Primary sponsor: Weill Medical College of Cornell University
• Public title: Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS
• Scientific title: Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS
• Date of first enrolment: June 2016
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02446886
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Susan Gauthier, DO
• Affiliation: Weill Cornell Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®)

Primary Outcome(s)

Primary Endpoint Change in Myelin Water Fraction (MWF) within new enhancing lesions over the course of 12 months [Time Frame: 12 months]

Secondary Outcome(s)

Additional secondary endpoint - clinical measurement (Change in T2 lesion volume) [Time Frame: 12 months]

Additional secondary endpoint - clinical measurement (Cortical Volume) [Time Frame: 12 months]

Additional secondary endpoint Absolute myelin content [Time Frame: 12 months]

Additional secondary endpoint - clinical measurement (Whole Brain Volume) [Time Frame: 12 months]

Additional secondary endpoint - clinical measurement (EDSS) [Time Frame: 12 months]

Main Secondary Endpoint longitudinal assessment of Myelin Water Fraction [Time Frame: 12 months]

Secondary ID(s)

1405015090

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt