Effects of Acthar on Recovery From Cognitive Relapses in MS

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Completed
CT.gov ID
NCT02290444
Collaborator
(none)
64
1
2
63
1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Adrenocorticotropic Hormone
Phase 3

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:
  1. 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.

  2. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple Sclerosis
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cognitively Relapsing Patients

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
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.
Other Names:
  • Acthar gel
  • No Intervention: Stable Multiple Sclerosis Patients

    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.

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline on the Symbol Digit Modalities Test (SDMT) [Day 0 and Day 90]

      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.

    2. Timed 25-foot Walk [Day 0 and Day 90]

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

    3. Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) [Day 0 and Day 90]

      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.

    4. Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) [Day 0 and Day 90]

      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.

    5. Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) [Day 0 and Day 90]

      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

    1. Change From Baseline on the Expanded Disability Status Scale (EDSS). [Day 0 and Day 90]

      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.

    2. Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) [Day 0 and Day 90]

      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.

    3. Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) [Day 0 and Day 90]

      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.

    4. Change From Baseline on the Fatigue Severity Scale (FSS) [Day 0 and Day 90]

      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.

    Other Outcome Measures

    1. Incidence of Adverse Events [Up to 3 months]

      The number of patients reporting adverse events over the course of the study

    2. Change From Baseline in Concurrent Medications [Up to 3 months]

      Initiation or discontinuation of any medications occurring over the course of the study; monitored by clinician and study personnel.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    1. Are capable of performing the requirements of neuropsychological (NP) testing, including near visual acuity 20/70 or better with correction.

    2. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital Buffalo New York United States 14203

    Sponsors and Collaborators

    • State University of New York at Buffalo

    Investigators

    • Principal Investigator: Ralph HB Benedict, PhD, University of Buffalo-State University of New York

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Ralph H.B. Benedict, Professor of Neurology and Psychiatry, State University of New York at Buffalo
    ClinicalTrials.gov Identifier:
    NCT02290444
    Other Study ID Numbers:
    • 465028
    First Posted:
    Nov 14, 2014
    Last Update Posted:
    Apr 6, 2020
    Last Verified:
    Apr 1, 2020
    Keywords provided by Ralph H.B. Benedict, Professor of Neurology and Psychiatry, State University of New York at Buffalo
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Period Title: Overall Study
    STARTED 30 34
    COMPLETED 29 32
    NOT COMPLETED 1 2

    Baseline Characteristics

    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients Total
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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. Total of all reporting groups
    Overall Participants 25 25 50
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    25
    100%
    25
    100%
    50
    100%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.4
    (10.7)
    43.8
    (10.5)
    43.1
    (10.6)
    Sex: Female, Male (Count of Participants)
    Female
    20
    80%
    22
    88%
    42
    84%
    Male
    5
    20%
    3
    12%
    8
    16%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    4%
    0
    0%
    1
    2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    2
    8%
    3
    12%
    5
    10%
    White
    22
    88%
    22
    88%
    44
    88%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Symbol Digit Modalities Test (Total Correct) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Total Correct]
    55.2
    (13.5)
    55.9
    (12.4)
    55.6
    (13.0)
    California Verbal Learning Test, 2nd Edition (Total Learning Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Total Learning Score]
    51.4
    (12.6)
    49.1
    (11.1)
    50.3
    (11.9)
    Brief Visuospatial Memory Test Revised (BVMTR) (Total Learning Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Total Learning Score]
    23.1
    (7.1)
    23.9
    (7.0)
    23.5
    (7.1)
    Timed 25-foot Walk (Seconds) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Seconds]
    5.4
    (1.9)
    5.0
    (1.2)
    5.2
    (1.6)
    Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) (Total Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Total Score]
    30.1
    (12.6)
    18.0
    (8.9)
    24.1
    (10.8)
    Expanded Disability Status Scale (EDSS) (Total Score) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [Total Score]
    2.5
    2.5
    2.5
    Fatigue Severity Scale (FSS) (Total Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Total Score]
    4.9
    (1.6)
    4.2
    (1.5)
    4.6
    (1.6)

    Outcome Measures

    1. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Total Correct]
    44.6
    (13.9)
    58.5
    (13.9)
    2. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Seconds]
    6.7
    (3.2)
    5.3
    (1.2)
    3. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Total Correct]
    40.1
    (12.2)
    47.0
    (14.3)
    4. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Total Learning Score]
    22.0
    (8.9)
    22.5
    (7.9)
    5. Primary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Total Learning Score]
    46.6
    (14.1)
    51.2
    (11.8)
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Median (Inter-Quartile Range) [Total Score]
    3.0
    2.0
    7. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Total Score]
    34.5
    (9.4)
    20.0
    (12.3)
    8. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Total Score]
    5.0
    (4.0)
    1.6
    (2.8)
    9. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    The sample used for final analysis was smaller than the total enrolled (see Participant Flow) because participants were excluded from the final analysis due to (1) withdrawal prior to follow-up, (2) occasional missing data from one or more timepoints, and (3) to optimize matching of the groups based on demographic characteristics.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    Measure Participants 25 25
    Mean (Standard Deviation) [Total Score]
    5.4
    (1.4)
    3.8
    (1.7)
    10. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    11. Other Pre-specified Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame For individual subjects the time period was 3 months. From the initial enrollment to study closure, total monitoring time was 4 years.
    Adverse Event Reporting Description At each visit and in the weeks between visits, subjects were asked if they were experiencing any adverse events.
    Arm/Group Title Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Arm/Group 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. Adrenocorticotropic Hormone: 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. 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.
    All Cause Mortality
    Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/25 (0%)
    Serious Adverse Events
    Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/25 (0%)
    Other (Not Including Serious) Adverse Events
    Cognitively Relapsing Patients Stable Multiple Sclerosis Patients
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/25 (0%)

    Limitations/Caveats

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

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Curtis Wojcik, Lab Coordinator
    Organization University at Buffalo
    Phone 7163230551
    Email cmwojcik@buffalo.edu
    Responsible Party:
    Ralph H.B. Benedict, Professor of Neurology and Psychiatry, State University of New York at Buffalo
    ClinicalTrials.gov Identifier:
    NCT02290444
    Other Study ID Numbers:
    • 465028
    First Posted:
    Nov 14, 2014
    Last Update Posted:
    Apr 6, 2020
    Last Verified:
    Apr 1, 2020