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ACTH for Fatigue in Multiple Sclerosis Patients (ACTH)

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ClinicalTrials.gov Identifier: NCT02315872
Recruitment Status : Completed
First Posted : December 12, 2014
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Providence Health & Services

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: ACTH Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.
Actual Study Start Date : May 22, 2015
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACTH
The study drug (ACTH 40 units) will be given subcutaneously twice weekly for 2 weeks. If the patient tolerates this dosage regimen, the dose will be increased to 80 units twice weekly. If the 80 unit dosage is not tolerated, the dosage will be reduced to 40 units twice weekly for the remainder of the 24 week participation. The weekly doses will be given 3 days apart, for example, on every Monday and Thursday or every Tuesday and Friday.
Drug: ACTH
ACTH injections twice weekly for 28 weeks.
Other Names:
  • Acthar Gel
  • Repository Corticotropin Injection

Placebo Comparator: Placebo
Placebo will be given subcutaneously twice weekly for 28 weeks.
Drug: Placebo
Placebo injections twice weekly for 28 weeks.
Other Name: Control




Primary Outcome Measures :
  1. Change in Fatigue [ Time Frame: 28 weeks ]
    Change in patient-reported levels of fatigue as measured by score on the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS). The full-length MFIS consists of 21 items. A higher score on the MFIS indicates a greater impact of fatigue on a patient's activities. The FSS is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Higher scores indicate a greater severity of fatigue.


Secondary Outcome Measures :
  1. Change in Depression [ Time Frame: 28 weeks ]
    Change in patient-reported depression as measured by the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item self-report multiple-choice inventory used as an indicator of the severity of depression. A higher score indicates a greater severity of depression.

  2. Change in Sleepiness [ Time Frame: 28 weeks ]
    Change in patient-reported daytime sleepiness as measure by the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'.

  3. Change in Quality of Life [ Time Frame: 28 weeks ]
    Change in patient-reported quality of life as measured by the 36-Item Short Form Health Survey (SF-36). The SF-36 is a 36-item, patient-reported survey of patient mental and physical health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315872


Locations
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United States, Alabama
North Central Neurology Associates, PC
Cullman, Alabama, United States, 35058
United States, Oregon
Providence Medical Group - Medford Neurology
Medford, Oregon, United States, 97504
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
MultiCare Health System -- Institute for Research and Innovation
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Providence Health & Services
Mallinckrodt
Investigators
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Principal Investigator: Stanely Cohan, MD, PhD Providence Health & Services
  Study Documents (Full-Text)

Documents provided by Providence Health & Services:

Additional Information:
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02315872     History of Changes
Other Study ID Numbers: 13-120A
First Posted: December 12, 2014    Key Record Dates
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Providence Health & Services:
Multiple Sclerosis
Acthar Gel
ACTH
Fatigue

Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Fatigue
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Adrenocorticotropic Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs