SHS_543082 BOWJ CPSV 14194

The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients with Relapsing Multiple Sclerosis

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

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 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 MFIS ≥ 38 or FSS ≥ 36, BDI-II greater than or equal to 19, and ESS 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 difficulty sleeping (not controlled with medication), sleep apnea, painful nocturnal spasms, nocturnal neuropathic pain, or 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 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
Phase III
Multiple Sclerosis
James Bowen, M.D.
Providence Health & Services
Yuriko Courtney
  • Swedish Medical Center