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

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ClinicalTrials.gov Identifier: NCT02446886
Recruitment Status : Recruiting
First Posted : May 18, 2015
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adrenocorticotropic Hormone (ACTH) Effects on Myelination in Subjects With MS
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A

MS patients enrolled in this study will be randomized into:

Intervention for Group A: 80 units/day ACTH (H.P. Acthar®)for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.)

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

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.

Other Names:
  • ACTH
  • H.P. Acthar®

Experimental: Group B
Intervention for Group B: 80 units/day ACTH (H.P. Acthar®) for 3-5 days (The dose could be adjusted based on the individual needs of the patients up to 80-120 units daily for 2-3 weeks.), followed by monthly 80 units/day ACTH for 3 days for 12 months of treatment.
Drug: Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®)

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.

Other Names:
  • ACTH
  • H.P. Acthar®




Primary Outcome Measures :
  1. Primary Endpoint Change in Myelin Water Fraction (MWF) within new enhancing lesions over the course of 12 months [ Time Frame: 12 months ]
    . The absolute change in lesion MWF (over our test-retest variability) between baseline and one year MRI's will be calculated and compared between treatment groups.


Secondary Outcome Measures :
  1. Main Secondary Endpoint longitudinal assessment of Myelin Water Fraction [ Time Frame: 12 months ]
    A longitudinal assessment of Myelin Water Fraction (MWF) (every 3 months) to determine the dynamics of myelin change over 12 months, specifically to determine the timing of remyelination.

  2. Additional secondary endpoint Absolute myelin content [ Time Frame: 12 months ]
    An exploratory measurement - . Through this measurement, we can control for the increased edema associated with a new lesion, thus providing for a more accurate measure of true myelin change.

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

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

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

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02446886


Contacts
Contact: Alexandra Kocsik 646-962-5736 alk3006@med.cornell.edu
Contact: Blagovest Nikolov, MD 212-746-9882 bln2001@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Principal Investigator: Susan Gauthier, DO         
Sponsors and Collaborators
Weill Medical College of Cornell University
Mallinckrodt
Investigators
Principal Investigator: Susan Gauthier, DO Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02446886     History of Changes
Other Study ID Numbers: 1405015090
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Weill Medical College of Cornell University:
Multiple Sclerosis
MS
RRMS
SPMS
ACTH

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Hormones
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action