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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 and Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | The number of patients reporting adverse events over the course of the study | Up to 3 months |
| Change From Baseline in Concurrent Medications | Initiation or discontinuation of any medications occurring over the course of the study; monitored by clinician and study personnel. |
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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph HB Benedict, PhD | University of Buffalo-State University of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16626751 | Background | Benedict RH, Zivadinov R. Predicting neuropsychological abnormalities in multiple sclerosis. J Neurol Sci. 2006 Jun 15;245(1-2):67-72. doi: 10.1016/j.jns.2005.05.020. Epub 2006 Apr 19. | |
| 18829629 | 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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Total Correct | Day 0 and Day 90 |
|
For individual subjects the time period was 3 months. From the initial enrollment to study closure, total monitoring time was 4 years.
At each visit and in the weeks between visits, subjects were asked if they were experiencing any adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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Because of withdrawals and/or incomplete data, some enrolled subjects were excluded from the final data analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Curtis Wojcik, Lab Coordinator | University at Buffalo | 7163230551 | cmwojcik@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2018 | Apr 1, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2018 | Apr 1, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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Not provided
|
|
| 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. | Day 0 and Day 90 |
| 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. | Day 0 and Day 90 |
| 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. | Day 0 and Day 90 |
| Up to 3 months |
| 9576548 | Background | Foong J, Rozewicz L, Quaghebeur G, Thompson AJ, Miller DH, Ron MA. Neuropsychological deficits in multiple sclerosis after acute relapse. J Neurol Neurosurg Psychiatry. 1998 Apr;64(4):529-32. doi: 10.1136/jnnp.64.4.529. |
| 17294621 | Background | 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. |
| 17623735 | Background | Glanz BI, Holland CM, Gauthier SA, Amunwa EL, Liptak Z, Houtchens MK, Sperling RA, Khoury SJ, Guttmann CR, Weiner HL. Cognitive dysfunction in patients with clinically isolated syndromes or newly diagnosed multiple sclerosis. Mult Scler. 2007 Sep;13(8):1004-10. doi: 10.1177/1352458507077943. Epub 2007 Jul 10. |
| 20084515 | Background | 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. |
| 21556031 | Background | Benedict RH, Zivadinov R. Risk factors for and management of cognitive dysfunction in multiple sclerosis. Nat Rev Neurol. 2011 May 10;7(6):332-42. doi: 10.1038/nrneurol.2011.61. |
| 17613607 | Background | Patti F, Pozzilli C, Montanari E, Pappalardo A, Piazza L, Levi A, Onesti E, Pesci I; Italian Study Group On Quality Of Life In Ms. Effects of education level and employment status on HRQoL in early relapsing-remitting multiple sclerosis. Mult Scler. 2007 Jul;13(6):783-91. doi: 10.1177/1352458506073511. Epub 2007 Feb 16. |
| 11724451 | Background | Amato MP, Ponziani G, Rossi F, Liedl CL, Stefanile C, Rossi L. Quality of life in multiple sclerosis: the impact of depression, fatigue and disability. Mult Scler. 2001 Oct;7(5):340-4. doi: 10.1177/135245850100700511. |
| 11594918 | Background | Amato MP, Ponziani G, Siracusa G, Sorbi S. Cognitive dysfunction in early-onset multiple sclerosis: a reappraisal after 10 years. Arch Neurol. 2001 Oct;58(10):1602-6. doi: 10.1001/archneur.58.10.1602. |
| 21384163 | Background | Morrow SA, Jurgensen S, Forrestal F, Munchauer FE, Benedict RH. Effects of acute relapses on neuropsychological status in multiple sclerosis patients. J Neurol. 2011 Sep;258(9):1603-8. doi: 10.1007/s00415-011-5975-3. Epub 2011 Mar 8. |
| 12607150 | Background | Benedict RH, Fischer JS, Archibald CJ, Arnett PA, Beatty WW, Bobholz J, Chelune GJ, Fisk JD, Langdon DW, Caruso L, Foley F, LaRocca NG, Vowels L, Weinstein A, DeLuca J, Rao SM, Munschauer F. Minimal neuropsychological assessment of MS patients: a consensus approach. Clin Neuropsychol. 2002 Aug;16(3):381-97. doi: 10.1076/clin.16.3.381.13859. |
| 16981607 | Background | Benedict RH, Cookfair D, Gavett R, Gunther M, Munschauer F, Garg N, Weinstock-Guttman B. Validity of the minimal assessment of cognitive function in multiple sclerosis (MACFIMS). J Int Neuropsychol Soc. 2006 Jul;12(4):549-58. doi: 10.1017/s1355617706060723. |
| Background | Smith A. Symbol digit modalities test: Manual. Los Angeles: Western Psychological Services, 1982. |
| Background | Benedict R. Brief Visuospatial Memory Test - Revised: Professional Manual. Odessa, Florida: Psychological Assessment Resources, 1997. |
| 866038 | Background | Gronwall DM. Paced auditory serial-addition task: a measure of recovery from concussion. Percept Mot Skills. 1977 Apr;44(2):367-73. doi: 10.2466/pms.1977.44.2.367. |
| 17613599 | Background | Benedict RH, Bruce J, Dwyer MG, Weinstock-Guttman B, Tjoa C, Tavazzi E, Munschauer FE, Zivadinov R. Diffusion-weighted imaging predicts cognitive impairment in multiple sclerosis. Mult Scler. 2007 Jul;13(6):722-30. doi: 10.1177/1352458507075592. Epub 2007 Mar 15. |
| 21486517 | Background | Benedict RH, Holtzer R, Motl RW, Foley FW, Kaur S, Hojnacki D, Weinstock-Guttman B. Upper and lower extremity motor function and cognitive impairment in multiple sclerosis. J Int Neuropsychol Soc. 2011 Jul;17(4):643-53. doi: 10.1017/S1355617711000403. |
| 11034713 | Background | Filippini G, Brusaferri F, Sibley WA, Citterio A, Ciucci G, Midgard R, Candelise L. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database Syst Rev. 2000;2000(4):CD001331. doi: 10.1002/14651858.CD001331. |
| 17920543 | Background | Shah A, Eggenberger E, Zivadinov R, Stuve O, Frohman EM. Corticosteroids for multiple sclerosis: II. Application for disease-modifying effects. Neurotherapeutics. 2007 Oct;4(4):627-32. doi: 10.1016/j.nurt.2007.07.009. |
| 17920542 | Background | Frohman EM, Shah A, Eggenberger E, Metz L, Zivadinov R, Stuve O. Corticosteroids for multiple sclerosis: I. Application for treating exacerbations. Neurotherapeutics. 2007 Oct;4(4):618-26. doi: 10.1016/j.nurt.2007.07.008. |
| 10467383 | Background | Fischer JS, Rudick RA, Cutter GR, Reingold SC. The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome assessment. National MS Society Clinical Outcomes Assessment Task Force. Mult Scler. 1999 Aug;5(4):244-50. doi: 10.1177/135245859900500409. |
| 2027484 | Background | Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685. |
| Background | Benedict RHB, Schretlen D, Groninger L, Dobraski M, Shpritz B. Revision of the Brief Visuospatial Memory Test: Studies of normal performance, reliability, and validity. Psychological Assessment 8:145-153, 1996. |
| 12617275 | 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. |
| 6685237 | Background | Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444. |
| 1200192 | Background | Gilson BS, Gilson JS, Bergner M, Bobbit RA, Kressel S, Pollard WE, Vesselago M. The sickness impact profile. Development of an outcome measure of health care. Am J Public Health. 1975 Dec;65(12):1304-10. doi: 10.2105/ajph.65.12.1304. No abstract available. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Symbol Digit Modalities Test | A measure of visual processing speed and working memory. Minimum score of 0, Maximum score of 120. Higher scores indicate better performance. | Mean | Standard Deviation | Total Correct |
|
| California Verbal Learning Test, 2nd Edition | Measure of verbal memory. Minimum 0, Maximum 60. Higher scores indicate better performance. | Mean | Standard Deviation | Total Learning Score |
|
| Brief Visuospatial Memory Test Revised (BVMTR) | A measure of visual-spatial memory. Minimum of 0, maximum of 36. Higher scores indicate better performance. | Mean | Standard Deviation | Total Learning Score |
|
| Timed 25-foot Walk | Measure of walking speed and ambulation, how fast can a subject walk 25 feet, measured in seconds. Ceiling value of 300 seconds. | Mean | Standard Deviation | Seconds |
|
| Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ) | Self-report measure of neuropsychological impairment. Minimum of 0, maximum of 60. Higher scores indicate greater self-reported neuropsychological impairment. | Mean | Standard Deviation | Total Score |
|
| 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. | Median | Inter-Quartile Range | Total Score |
|
| Fatigue Severity Scale (FSS) | Self-report measure of fatigue on 1 (minimum) to 9 (severe fatigue) scale. | Mean | Standard Deviation | Total Score |
|
| OG001 | 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. |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Seconds | Day 0 and Day 90 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Total Correct | Day 0 and Day 90 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Total Learning Score | Day 0 and Day 90 |
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Total Learning Score | Day 0 and Day 90 |
|
|
|
| Secondary | 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. | 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. | Posted | Median | Inter-Quartile Range | Total Score | Day 0 and Day 90 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Total Score | Day 0 and Day 90 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Total Score | Day 0 and Day 90 |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Total Score | Day 0 and Day 90 |
|
|
|
| Other Pre-specified | Incidence of Adverse Events | The number of patients reporting adverse events over the course of the study | Not Posted | Up to 3 months | Participants |
| Other Pre-specified | Change From Baseline in Concurrent Medications | Initiation or discontinuation of any medications occurring over the course of the study; monitored by clinician and study personnel. | Not Posted | Up to 3 months | Participants |
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |