ACTH for Fatigue in Multiple Sclerosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02315872
• Date of registration: 09/12/2014
• Prospective Registration: Yes
• Primary sponsor: Providence Health & Services
• Public title: ACTH for Fatigue in Multiple Sclerosis Patients ACTH
• Scientific title: The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.
• Date of first enrolment: May 22, 2015
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02315872
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Stanely Cohan, MD, PhD
• Affiliation: Providence Health & Services

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis, Relapsing-Remitting

Intervention(s)

Drug: Placebo

Drug: ACTH

Primary Outcome(s)

Fatigue at 28 Weeks [Time Frame: 28 weeks]

Secondary Outcome(s)

Sleepiness at 28 Weeks [Time Frame: 28 weeks]

Quality of Life at 28 Weeks [Time Frame: 28 weeks]

Depression at 28 Weeks [Time Frame: 28 weeks]

Secondary ID(s)

13-120A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mallinckrodt

Results

• Results available: Yes
• Date Posted: 13/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02315872