ACTH for Fatigue in Multiple Sclerosis Patients

Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Age Range:18 - 65
Start Date:December 2014
End Date:December 2019
Contact:Lynette Currie

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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.

This is a multi-center, randomized, double-blind, placebo-controlled study to demonstrate the
safety, tolerability, and effect of ACTH on fatigue in patients with relapsing multiple
sclerosis (RMS). The primary objective of this study is to assess the efficacy of ACTH versus
placebo in reducing fatigability in patients with RMS. Secondary objectives include
assessment of the tolerability and safety of twice-weekly ACTH treatment vs. placebo and
evaluation of ACTH on depression, sleepiness, and quality of life measures and correlations
between these measures.

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 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

- Had a relapse or documented objective neurologic worsening in 90 days prior to

- 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
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