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Trial record 1 of 1 for:    NCT01950234
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ACTH in Progressive Forms of MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950234
Recruitment Status : Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1) pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of clinical and paraclinical measures of MS progression compared to placebo.

Condition or disease Intervention/treatment Phase
Secondary Progressive Multiple Sclerosis Primary Progressive Multiple Sclerosis Progressive Relapsing Multiple Sclerosis Drug: ACTH Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)
Study Start Date : October 2013
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACTH
ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month
Drug: ACTH
Acthar gel
Other Name: Acthar gel

Placebo Comparator: Placebo
Placebo subcutaneous injections administered on 3 consecutive days per month
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of patients exhibiting a 20% worsening in T25FW at 36 months [ Time Frame: Month 36 ]

Secondary Outcome Measures :
  1. Safety and tolerability of ACTH [ Time Frame: Month 36 ]
    Safety and tolerability will be assessed via safety lab tests, skin and edema assessments, DEXA scans, symptom questionnaires and adverse event assessments.


Other Outcome Measures:
  1. Slowed progression of sustained cognitive disability [ Time Frame: Month 36 ]
    Brief Repeatable Battery of Neuropsychological Tests (BRB-N)

  2. Retinal nerve fiber layer thickness [ Time Frame: Month 36 ]
    Decline in retinal nerve fiber layer thickness as measured by optical coherence tomography (OCT)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients with a confirmed diagnosis of MS by McDonald criteria
  • Age >/= 18 years
  • SPMS, PPMS, or PRMS phenotype, according to Lublin and Reingold criteria
  • EDSS 2.0 - 6.0, inclusive
  • Able to understand the consent process

Exclusion Criteria:

  • Known intolerance of ACTH or corticosteroids
  • Diabetes mellitus, defined as pre-existing diagnosis, fasting blood glucose > 125 mg/dl, or glycosylated hemoglobin >/= 6.5%
  • Osteoporosis, defined as pre-existing diagnosis or T-score on dual-energy x-ray absorptiometry (DEXA) scan of </= -2.5.
  • Current serious medical condition which may interfere with subject's ability to complete the study, or for which pulsed ACTH therapy is contraindicated or might complicate current therapy (e.g., cancer, severe psychiatric illness, chronic infections, autoimmune disorders)
  • Treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization
  • Treatment with non-cytotoxic immunosuppressive agents (including but not necessarily limited to corticosteroids, ACTH, azathioprine, mycophenolate mofetil, methotrexate or natalizumab) within 3 months prior to randomization
  • Treatment with FDA-approved first-line MS disease-modifying therapies (B-interferon, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) will be permitted, as long as treatment has been ongoing and stable for at least 3 months prior to randomization
  • Treatment with dalfampridine or compounded 4-aminopyridine (4-AP) will be permitted as long as treatment has been ongoing and stable for at least 3 months prior to randomization
  • Stimulant medications for fatigue (such as methylphenidate, modafinil, armodafinil, amantadine or dextroamphetamine) will be permitted, but subjects will be asked to not take these medications on study visit days until all study procedures/assessments are completed.

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): NCT01950234


Locations
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United States, Minnesota
Clinical Neuroscience Research Unit, University of Minnesota
Minneapolis, Minnesota, United States, 55414
United States, North Dakota
Sanford Clinic Neuroscience
Fargo, North Dakota, United States, 58103
United States, Wisconsin
Wheaton Franciscan Healthcare - St Francis Center for Neurological Disorders
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
University of Minnesota
Mallinckrodt
Investigators
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Principal Investigator: Adam F Carpenter, MD University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01950234    
Other Study ID Numbers: 1308M41681
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs