ACTH for Fatigue in Multiple Sclerosis Patients
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Fatigue
Intervention: ACTH; Placebo
Intervention description: ACTH injections twice weekly for 28 weeks.; Placebo injections twice weekly for 28 weeks.
Intervention MeSH terms: Adrenocorticotropic Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Acthar Gel; ACTH; Fatigue

Summary:

      This is a study of Acthar gel (ACTH) in patients with relapsing multiple sclerosis who are
      experiencing chronic fatigue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have documented diagnosis of Relapsing MS as defined by McDonald Criteria 2011
             Revision for at least 6 months

          -  Have been treated with interferon beta 1a or 1b, glatiramer acetate, fingolimod,
             dimethyl fumarate, or teriflunomide for at least 6 months, with reported adherence
             rate of at least 75%, at time of screening

          -  Have an Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 4, inclusive

          -  Have Modified Fatigue Impact Scale (MFIS) ≥ 38 or Functional Systems Scores (FSS) ≥
             36, Beck Depression Inventory-II (BDI-II) greater than or equal to 19, and Expanded
             Disability Status Scale (EDSS) greater than or equal to 9

          -  Women of childbearing potential must employ proven methods to prevent pregnancy during
             the course of the trial

          -  Able to understand the purpose and risks of the study

          -  Must be willing to sign an inform consent

          -  Must be willing to follow the protocol requirements

          -  Subject must agree not to receive any live or live-attenuated vaccine during the trial

        Exclusion Criteria:

          -  Have any of the contraindications for Acthar Gel as listed in the approved label,
             including sensitivity to proteins of porcine origin.

          -  Had treatment of systemic or oral corticosteroids of any type in 90 days prior to
             baseline/randomization

          -  Had a relapse or documented objective neurologic worsening in 90 days prior to
             baseline/randomization

          -  Has concurrent neurological disease other than multiple sclerosis

          -  History of sleep apnea

          -  History (within 90 days) of nocturnal pain and / or nocturnal spasms that interferes
             with or disrupts sleep, or uncontrolled nocturnal restless leg syndrome

          -  History of psychosis, bipolar disorder, mania/hypomania

          -  History of coronary heart disease, congestive heart failure, chronic pulmonary
             disease, emphysema, anemia, bleeding disorder, gastrointestinal bleeding, intestinal
             ulcer, clinically significant cardiac arrhythmia, Type I or II diabetes, uncontrolled
             hypertension, seizure disorder, cardiac arrhythmia, immune deficiency disorder,
             HIV-AIDS, tuberculosis, or dysthyroidal state (patients with a history of
             hypothyroidism or hyperthyroidism, which has been corrected to physiological levels
             will not be excluded)

          -  History of substance abuse, other than tobacco within the past 5 years or current
             alcohol dependence

          -  Current use of cannabis, opiates, benzodiazepines, barbiturates, gabapentin,
             pregabalin, topiramate, divalproex sodium, carbamazepine, oxcarbazepine, or any
             gaba-ergic medications other than tizanidine or Baclofen, which are permitted for
             spasticity treatment

          -  History of any malignant neoplasm except for past basal cell or squamous cell
             carcinoma of the skin, that has been successfully treated prior to the screening visit

          -  History of psychosis or history of use of neuroleptics including, but not restricted
             to, haloperidol, chlorpromazine, aripiprazole, olanzapine, risperidone

          -  History of suicide attempt, current suicidal thinking or is preparing for suicide

          -  Current use of Amphetamines or methylphenidate

          -  Current use of modafinil, or armodafinil

          -  Current use of amantidine

          -  The subject must have had a medication-free interval of:

             a. 7 days for prior use of: i. methylphenidate, amphetamine or dextroamphetamine ii.
             modafinil or armodafinil iii. diphenhydramine, phenylephrine, loratadine iv.
             gabapentin, pregabalin, topiramate, valproate/divalproex v. oxcarbazepine vi. codeine,
             hydrocodone, oxycodone, diphenhydramine, phenylephrine, gabapentin, pregabalin,
             topiramate, valproate/divalproex, oxcarbazepine, codeine, hydrocodone, oxycodone b. 14
             days for prior use of: i. desloratadine ii. Amantidine iii. alprazolam, lorazepam,
             morphine, hydromorphone, amantidine, alprazolam, lorazepam iv. morphine, hydromorphone
             c. 28 days for prior use of: i. clonazepam ii. cannabis or other cannabinoids d. 90
             days for prior use of carbamazepine