Clinical trial NCT02315872: ACTH for Fatigue in Multiple Sclerosis Patients
Official title: The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis
Acthar Gel
ACTH
Fatigue
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2014-12-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

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

Primary outcomes:
measure: Fatigue at 28 Weeks
timeFrame: 28 weeks
Secondary outcomes:
measure: Depression at 28 Weeks
timeFrame: 28 weeks
measure: Sleepiness at 28 Weeks
timeFrame: 28 weeks
measure: Quality of Life at 28 Weeks
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Cullman
country: United States
facility: North Central Neurology Associates, PC
state: Alabama
city: Medford
country: United States
facility: Providence Medical Group - Medford Neurology
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System -- Institute for Research and Innovation
state: Washington
Study officials:
affiliation: Providence Health & Services
name: Stanely Cohan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: