ACTH for Fatigue in Multiple Sclerosis Patients

NCT02315872 | Completed Phase 3 Results DMC

• 1 other identifier: 13-120A
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis; Acthar Gel; ACTH; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Depression at 28 Weeks

  28 weeks

• Sleepiness at 28 Weeks

  28 weeks

• Quality of Life at 28 Weeks

  28 weeks

Study Arms (2)

ACTH

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo will be given subcutaneously twice weekly for 28 weeks.

Drug: Placebo

Interventions

ACTH DRUG

ACTH injections twice weekly for 28 weeks.

Also known as: Acthar Gel, Repository Corticotropin Injection

ACTH

Placebo DRUG

Placebo injections twice weekly for 28 weeks.

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Providence Health & Services: lead
• Mallinckrodt: collaborator

Study Sites (5)

North Central Neurology Associates, PC

Cullman, Alabama, 35058, United States

Location

Providence Medical Group - Medford Neurology

Medford, Oregon, 97504, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

MultiCare Health System -- Institute for Research and Innovation

Tacoma, Washington, 98405, United States

Location

Related Links

• Providence Health \& Services Brain and Spine Institute

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Fatigue

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Lynette Currie
• Organization: Providence Health & Services

lynette.currie@providence.org

503-216-1034

Study Officials

• Stanely Cohan, MD, PhD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: May 22, 2015
• Primary Completion: June 20, 2017
• Study Completion: December 13, 2018
• Last Updated: September 9, 2019
• Results First Posted: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)