ACTH in Progressive Forms of MS

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborator:
Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01950234
First received: August 30, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Secondary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
Drug: ACTH
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Proportion of patients exhibiting a 20% worsening in T25FW at 36 months [ Time Frame: Month 36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of ACTH [ Time Frame: Month 36 ] [ Designated as safety issue: Yes ]
    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:
  • Slowed progression of sustained cognitive disability [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Brief Repeatable Battery of Neuropsychological Tests (BRB-N)

  • Retinal nerve fiber layer thickness [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Decline in retinal nerve fiber layer thickness as measured by optical coherence tomography (OCT)


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950234

Contacts
Contact: Susan Rolandelli, RN 612-624-7745 cnru@umn.edu

Locations
United States, Minnesota
Clinical Neuroscience Research Unit, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Susan Rolandelli, RN    612-624-7745    cnru@umn.edu   
Principal Investigator: Adam F Carpenter, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Questcor Pharmaceuticals, Inc.
Investigators
Principal Investigator: Adam F Carpenter, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01950234     History of Changes
Other Study ID Numbers: ACTH-20712
Study First Received: August 30, 2013
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014