ACTH for Fatigue in Multiple Sclerosis Patients

• Status: Completed
• Trial end date: 2018-12-13
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Providence Health & Services
• Collaborator: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

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