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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

Tracking Information
First Submitted Date  ICMJE August 30, 2013
First Posted Date  ICMJE September 25, 2013
Last Update Posted Date November 6, 2019
Study Start Date  ICMJE October 2013
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2013)
Proportion of patients exhibiting a 20% worsening in T25FW at 36 months [ Time Frame: Month 36 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 20, 2013)
  • Slowed progression of sustained cognitive disability [ Time Frame: Month 36 ]
    Brief Repeatable Battery of Neuropsychological Tests (BRB-N)
  • Retinal nerve fiber layer thickness [ Time Frame: Month 36 ]
    Decline in retinal nerve fiber layer thickness as measured by optical coherence tomography (OCT)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE ACTH in Progressive Forms of MS
Official Title  ICMJE Treatment of Progressive Forms of Multiple Sclerosis With Pulsed ACTH (Acthar Gel)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Secondary Progressive Multiple Sclerosis
  • Primary Progressive Multiple Sclerosis
  • Progressive Relapsing Multiple Sclerosis
Intervention  ICMJE
  • Drug: ACTH
    Acthar gel
    Other Name: Acthar gel
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: ACTH
    ACTH administered subcutaneously as a pulsed regimen of 3 consecutive days per month
    Intervention: Drug: ACTH
  • Placebo Comparator: Placebo
    Placebo subcutaneous injections administered on 3 consecutive days per month
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2013)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01950234
Other Study ID Numbers  ICMJE 1308M41681
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Adam F Carpenter, MD University of Minnesota
PRS Account University of Minnesota
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP