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Effects of Acthar on Recovery From Cognitive Relapses in MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Adrenocorticotropic Hormone
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Acute Relapsing Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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).
  2. Have a diagnosis of Relapsing Remitting MS (RRMS) or early Secondary Progressive MS (SPMS) as per revised McDonald's Criteria.
  3. Have an Expanded Disability Severity Scale (EDSS) of ≤ 7.0.
  4. Have had valid neuropsychological testing (NP) within the past 4 years

  5. 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.

    • Confirmation of cognitive decline will be obtained by administering the Symbol Digit Modalities Test (SDMT) as a screening procedure for the study and comparing it to scores obtained within 4 years (see inclusion criteria #4). Participants qualify if a raw point change on the SDMT greater than or equal to -3 points is detected.
  6. Are capable of performing the requirements of neuropsychological (NP) testing, including near visual acuity 20/70 or better with correction.
  7. 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.

Exclusion Criteria:

  1. Are found to have evidence on MRI of new lesions in the brainstem, spinal cord, or optic nerve.
  2. Have clear new physical signs or symptoms that are referable to the cord, brainstem or optic nerve.
  3. Have cognitive deficits/impairment caused by concomitant medication usage, or are attributable to another medical condition or significant neurological/psychological disease.
  4. Have evidence of current major depression as determined by a positive Beck Depression Inventory-Fast Screen (BDI-FS) and clinician interview.
  5. 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.
  6. Are taking any medication, or have any medical condition contraindicated with Acthar.
  7. Presence of current infections as determined by clinician interview.
  8. Are currently nursing, intentionally seeking pregnancy, or deemed at-risk for unplanned pregnancy.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitively Relapsing Patients

Stable Multiple Sclerosis Patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Change From Baseline on the Expanded Disability Status Scale (EDSS).
A clinician assigned measure of disability specific to MS. Minimum of 0 (no disability), maximum of 10 (death due to MS). Higher scores indicate greater disability. The difference in total score on the EDSS from Day 0 to Day 90 were analyzed to address change in this outcome.
Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
A self and informant rating measure of perceived cognitive problems. Minimum of 0, maximum of 60. Higher scores indicates greater self-reported neuropsychological impairment. The difference in total score on the MSNQ from Day 0 to Day 90 were analyzed to address change in this outcome.
Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
A self-report, multiple choice inventory of depression. Minimum of 0, maximum of 21. Higher score indicates higher levels of depression. The difference in total score on the BDI-FS from Day 0 to Day 90 were analyzed to address change in this outcome.
Change From Baseline on the Fatigue Severity Scale (FSS)
A self-report measure of fatigue. 1 (no fatigue) to 9 (severe fatigue). The difference in total score on FSS from Day 0 to Day 90 were analyzed to address change in this outcome.

Full Information

First Posted
October 23, 2014
Last Updated
April 1, 2020
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT02290444
Brief Title
Effects of Acthar on Recovery From Cognitive Relapses in MS
Official Title
Effects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a prospective, open-label study of Acthar administered as treatment for an acute cognitive relapse. Primary and secondary endpoints will be collected prior to Acthar administration and at 3-month follow-up. Comparison will be made to a stable MS control group. The objectives of the study are: To replicate prior findings with steroid therapy for MS patients for cognitive relapses, using instead Acthar Gel as the treating agent. The investigators will determine if the decrease on cognitive endpoints at the time of relapse exceeds that of stable MS controls. To compare the effects above to a previously acquired dataset of relapsing patients treated with steroids. This is a quasi-experimental design in so far as the steroid treated group data were previously acquired in a separate study. The primary hypothesis of the study is that, due to the enhanced melanocortin response in Acthar the recovery from cognitive changes occurring during cognitively focused relapse will be significant compared to stable MS patients matched on age, time since testing, and cognitive performance on the SDMT. Target enrollment for the Acthar treatment group will be 30 MS patients under care at the Jacobs Neurological Institute with existing neuropsychological baseline in the past four years in whom a cognitive relapse or new supratentorial GAD enhancing lesion(s) on MRI have been identified. Cognitive relapse will be identified based on clinical presentation of acute worsening of cognitive symptoms in the domains of processing speed, concentration, episodic memory, working memory, and/or fatigue. Patients whose clinical MRI indicate new active GAD enhancing lesions will be screened for the presence of self-perceived cognitive decline, without new physical symptoms. Thirty (30) clinically stable MS patients matched on age, time since testing, and cognitive performance on the SDMT will be recruited from the pool of patients with existing cognitive baselines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Acute Relapsing Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitively Relapsing Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Stable Multiple Sclerosis Patients
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Adrenocorticotropic Hormone
Other Intervention Name(s)
Acthar gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline on the Symbol Digit Modalities Test (SDMT)
Description
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.
Time Frame
Day 0 and Day 90
Title
Timed 25-foot Walk
Description
An MS-specific measure of functional status walking speed. How many seconds does it take to walk 25 feet. Ceiling value of 300 seconds.
Time Frame
Day 0 and Day 90
Title
Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)
Description
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.
Time Frame
Day 0 and Day 90
Title
Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
Description
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.
Time Frame
Day 0 and Day 90
Title
Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
Description
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.
Time Frame
Day 0 and Day 90
Secondary Outcome Measure Information:
Title
Change From Baseline on the Expanded Disability Status Scale (EDSS).
Description
A clinician assigned measure of disability specific to MS. Minimum of 0 (no disability), maximum of 10 (death due to MS). Higher scores indicate greater disability. The difference in total score on the EDSS from Day 0 to Day 90 were analyzed to address change in this outcome.
Time Frame
Day 0 and Day 90
Title
Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
Description
A self and informant rating measure of perceived cognitive problems. Minimum of 0, maximum of 60. Higher scores indicates greater self-reported neuropsychological impairment. The difference in total score on the MSNQ from Day 0 to Day 90 were analyzed to address change in this outcome.
Time Frame
Day 0 and Day 90
Title
Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
Description
A self-report, multiple choice inventory of depression. Minimum of 0, maximum of 21. Higher score indicates higher levels of depression. The difference in total score on the BDI-FS from Day 0 to Day 90 were analyzed to address change in this outcome.
Time Frame
Day 0 and Day 90
Title
Change From Baseline on the Fatigue Severity Scale (FSS)
Description
A self-report measure of fatigue. 1 (no fatigue) to 9 (severe fatigue). The difference in total score on FSS from Day 0 to Day 90 were analyzed to address change in this outcome.
Time Frame
Day 0 and Day 90
Other Pre-specified Outcome Measures:
Title
Incidence of Adverse Events
Description
The number of patients reporting adverse events over the course of the study
Time Frame
Up to 3 months
Title
Change From Baseline in Concurrent Medications
Description
Initiation or discontinuation of any medications occurring over the course of the study; monitored by clinician and study personnel.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Confirmation of cognitive decline will be obtained by administering the Symbol Digit Modalities Test (SDMT) as a screening procedure for the study and comparing it to scores obtained within 4 years (see inclusion criteria #4). Participants qualify if a raw point change on the SDMT greater than or equal to -3 points is detected. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralph HB Benedict, PhD
Organizational Affiliation
University of Buffalo-State University of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

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Effects of Acthar on Recovery From Cognitive Relapses in MS

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