Clinical Trial Details

NCT ID: NCT02315872
Date Last Changed: September 26, 2016

Overview

Research Study Summary

A clinical trial to evaluate treatments using ACTH and Placebo for patients with Multiple Sclerosis, Relapsing-Remitting

Research Study Title

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

Purpose

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

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 to 65 Years
Overall Status
Recruiting
Lead Sponsor
Providence Health & Services
Duration
48 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years to 65 Years

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 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

Site Locations (6)

Country State City Zip Facility and Contact
United States Alabama Cullman 35058 North Central Neurology Associates, PC
Mitzi Roberts
256-739-9245
mroberts@prn-inc.net

Christopher LaGanke, MD
Principal Investigator
United States Oregon Medford 97504 Providence Medical Group - Medford Neurology
Kari Jaasko
541-732-8457
kari.jaasko@providence.org

Walter Carlini, MD, PhD
Principal Investigator
United States Oregon Portland 97225 Providence St. Vincent Medical Center
United States Utah Salt Lake City 84103 Rocky Mountain Research Group
Laura Seawright
801-408-4584
lseawright@rockymountainmsclinic.com

John Foley, MD
Principal Investigator
United States Washington Seattle 98122 Swedish Medical Center
Yuriko Courtney
206-320-2647
Yuriko.Courney@swedish.org

James Bowen, MD
Principal Investigator
United States Washington Tacoma 98405 MultiCare Health System -- Institute for Research and Innovation
Jarrod Monroe
253-403-7449
jarrod.monroe@multicare.org

John Huddlestone, MD
Principal Investigator

Contact

Hannah Voss
503-216-1193
E-mail:

DISCLAIMER: CenterWatch does not conduct clinical research. CenterWatch is a publishing company that posts clinical trials information on behalf of sponsor companies, contract research organizations, clinical research sites and other interested parties. This information is designed to help patients find clinical trials of interest and contact the research centers conducting the trials.