ACTH for Fatigue in Multiple Sclerosis Patients

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— ACTH  

Official title:

The Effect of ACTH (Acthar) on Measures of Chronic Fatigue in Patients With Relapsing Multiple Sclerosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315872
• Other study ID #: 13-120A
• Status: Completed
• Phase: Phase 3
• Start date: May 22, 2015
• Est. completion date: December 13, 2018

Study information

• Verified date: August 2019
• Source: Providence Health & Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 13, 2018
• Est. primary completion date: June 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• ACTH
ACTH injections twice weekly for 28 weeks.
• Placebo
Placebo injections twice weekly for 28 weeks.

Locations

Country	Name	City	State
United States	North Central Neurology Associates, PC	Cullman	Alabama
United States	Providence Medical Group - Medford Neurology	Medford	Oregon
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Swedish Medical Center	Seattle	Washington
United States	MultiCare Health System -- Institute for Research and Innovation	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Providence Health & Services	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue at 28 Weeks	Patient-reported levels of fatigue as measured by score on the Modified Fatigue Impact Scale (MFIS) and the Fatigue Severity Scale (FSS) at 28 weeks. 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 on each scale indicate a greater severity of fatigue.	28 weeks
Secondary	Depression at 28 Weeks	Patient-reported depression as measured by the Beck Depression Inventory-II (BDI-II) at 28 weeks. 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.	28 weeks
Secondary	Sleepiness at 28 Weeks	Patient-reported daytime sleepiness as measure by the Epworth Sleepiness Scale (ESS) at 28 weeks. 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'.	28 weeks
Secondary	Quality of Life at 28 Weeks	Patient-reported quality of life as measured by the 36-Item Short Form Health Survey (SF-36) at 28 weeks. 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.	28 weeks

External Links

•   Providence Health & Services Brain and Spine Institute