Effects of Acthar on Recovery From Cognitive Relapses in MS

NCT02290444 | Completed Phase 3 Results DMC

• 1 other identifier: 465028
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of a medication called Acthar on recovery from multiple sclerosis-related relapses that impact cognition.

Conditions

Multiple Sclerosis

Keywords

Acute Relapsing Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

Outcome Measures

Primary Outcomes (5)

• Change From Baseline on the Symbol Digit Modalities Test (SDMT)

  A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. The difference in total correct responses on the SDMT from Day 0 to Day 90 were analyzed to address change in this outcome.

  Day 0 and Day 90

• Timed 25-foot Walk

  An MS-specific measure of functional status walking speed. How many seconds does it take to walk 25 feet. Ceiling value of 300 seconds.

  Day 0 and Day 90

• Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)

  A measure of auditory processing speed and working memory. Minimum value of 0, maximum value of 60. Higher score indicates better performance. The difference in total correct on the PASAT from Day 0 to Day 90 were analyzed to address change in this outcome.

  Day 0 and Day 90

• Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)

  A measure of visual/spatial memory. Minimum of 0, maximum of 36. Higher score indicates better performance. The difference in total learning score on the BVMT-R from Day 0 to Day 90 were analyzed to address change in this outcome.

  Day 0 and Day 90

• Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)

  A measure of auditory/verbal episodic memory. Minimum of 0, maximum of 80. Higher score indicates better performance. The difference in total learning score on the CVLT-II from Day 0 to Day 90 were analyzed to address change in this outcome.

  Day 0 and Day 90

Secondary Outcomes (4)

• Change From Baseline on the Expanded Disability Status Scale (EDSS).

  Day 0 and Day 90

• Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)

  Day 0 and Day 90

• Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)

  Day 0 and Day 90

• Change From Baseline on the Fatigue Severity Scale (FSS)

  Day 0 and Day 90

Other Outcomes (2)

• Incidence of Adverse Events

  Up to 3 months

• Change From Baseline in Concurrent Medications

  Up to 3 months

Study Arms (2)

Cognitively Relapsing Patients

EXPERIMENTAL

For individuals experiencing cognitive relapses/exacerbations, 5ml/80 IU of Adrenocorticotropic Hormone will be administered through either subcutaneous or intramuscular self-injection (selected by the patient) for 5-days.

Drug: Adrenocorticotropic Hormone

Stable Multiple Sclerosis Patients

NO INTERVENTION

Individuals whose Multiple Sclerosis is currently in a stable state (not currently or recently exacerbating) are age-matched with relapsing MS patients. There is no intervention for individuals with MS whose are currently in a stable state.

Interventions

Adrenocorticotropic Hormone DRUG

Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.

Also known as: Acthar gel

Cognitively Relapsing Patients

Eligibility Criteria

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

You may qualify if:

• Males/Females between 18 and 65 years of age who are capable of understanding and complying with the protocol (ie. have completed at least a 9th grade education and are fluent English).
• Have a diagnosis of Relapsing Remitting MS (RRMS) or early Secondary Progressive MS (SPMS) as per revised McDonald's Criteria.
• Have an Expanded Disability Severity Scale (EDSS) of ≤ 7.0.
• Have had valid neuropsychological testing (NP) within the past 4 years
• Experiencing an acute cognitive relapse identified by a clinical care provider as a.) a cognitive symptom of recent origin developing over 48 hours, or b.) supratentorial GAD enhancing lesions on MRI with confirmed cognitive decline.
• Are capable of performing the requirements of neuropsychological (NP) testing, including near visual acuity 20/70 or better with correction.
• Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.

You may not qualify if:

• Are found to have evidence on MRI of new lesions in the brainstem, spinal cord, or optic nerve.
• Have clear new physical signs or symptoms that are referable to the cord, brainstem or optic nerve.
• Have cognitive deficits/impairment caused by concomitant medication usage, or are attributable to another medical condition or significant neurological/psychological disease.
• Have evidence of current major depression as determined by a positive Beck Depression Inventory-Fast Screen (BDI-FS) and clinician interview.
• Patients with changes to medications known to influence cognition (narcotics, stimulants, etc.) or disease modifying therapy within one month of study initiation (or within a time frame deemed high risk by treating physician) will be excluded.
• Are taking any medication, or have any medical condition contraindicated with Acthar.
• Presence of current infections as determined by clinician interview.
• Are currently nursing, intentionally seeking pregnancy, or deemed at-risk for unplanned pregnancy.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital

Buffalo, New York, 14203, United States

Location

Related Publications (27)

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  PMID: 16626751 BACKGROUND

• Benedict RH, Ramasamy D, Munschauer F, Weinstock-Guttman B, Zivadinov R. Memory impairment in multiple sclerosis: correlation with deep grey matter and mesial temporal atrophy. J Neurol Neurosurg Psychiatry. 2009 Feb;80(2):201-6. doi: 10.1136/jnnp.2008.148403. Epub 2008 Oct 1.

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• Feuillet L, Reuter F, Audoin B, Malikova I, Barrau K, Cherif AA, Pelletier J. Early cognitive impairment in patients with clinically isolated syndrome suggestive of multiple sclerosis. Mult Scler. 2007 Jan;13(1):124-7. doi: 10.1177/1352458506071196.

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• Simmons RD, Tribe KL, McDonald EA. Living with multiple sclerosis: longitudinal changes in employment and the importance of symptom management. J Neurol. 2010 Jun;257(6):926-36. doi: 10.1007/s00415-009-5441-7. Epub 2010 Jan 19.

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  BACKGROUND

• Benedict RH, Munschauer F, Linn R, Miller C, Murphy E, Foley F, Jacobs L. Screening for multiple sclerosis cognitive impairment using a self-administered 15-item questionnaire. Mult Scler. 2003 Feb;9(1):95-101. doi: 10.1191/1352458503ms861oa.

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MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

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; Chronic Disease; Disease Attributes; Pathologic Processes; 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

Limitations and Caveats

Because of withdrawals and/or incomplete data, some enrolled subjects were excluded from the final data analysis.

Results Point of Contact

• Title: Curtis Wojcik, Lab Coordinator
• Organization: University at Buffalo

cmwojcik@buffalo.edu

7163230551

Study Officials

• Ralph HB Benedict, PhD

  University of Buffalo-State University of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and Psychiatry

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 14, 2014
• Study Start: August 1, 2013
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-04

Locations

US (1)