Effects of Acthar on Recovery From Cognitive Relapses in MS
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Corticotropin
Melanocortin receptor 2 agonist
Results by group
Change From Baseline on the Symbol Digit Modalities Test (SDMT)
Day 0 and Day 90
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitively Relapsing Patients | 44.6 Total Correct | 13.9 (Standard Deviation) | 25 |
| Stable Multiple Sclerosis Patients | 58.5 Total Correct | 13.9 (Standard Deviation) | 25 |
Cognitively Relapsing Patients
Stable Multiple Sclerosis Patients
Timed 25-foot Walk
Day 0 and Day 90
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitively Relapsing Patients | 6.7 Seconds | 3.2 (Standard Deviation) | 25 |
| Stable Multiple Sclerosis Patients | 5.3 Seconds | 1.2 (Standard Deviation) | 25 |
Cognitively Relapsing Patients
Stable Multiple Sclerosis Patients
Change From Baseline on the Paced Auditory Serial Addition Test (PASAT)
Day 0 and Day 90
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitively Relapsing Patients | 40.1 Total Correct | 12.2 (Standard Deviation) | 25 |
| Stable Multiple Sclerosis Patients | 47.0 Total Correct | 14.3 (Standard Deviation) | 25 |
Cognitively Relapsing Patients
Stable Multiple Sclerosis Patients
Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
Day 0 and Day 90
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitively Relapsing Patients | 22.0 Total Learning Score | 8.9 (Standard Deviation) | 25 |
| Stable Multiple Sclerosis Patients | 22.5 Total Learning Score | 7.9 (Standard Deviation) | 25 |
Cognitively Relapsing Patients
Stable Multiple Sclerosis Patients
Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
Day 0 and Day 90
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Cognitively Relapsing Patients | 46.6 Total Learning Score | 14.1 (Standard Deviation) | 25 |
| Stable Multiple Sclerosis Patients | 51.2 Total Learning Score | 11.8 (Standard Deviation) | 25 |
Cognitively Relapsing Patients
Stable Multiple Sclerosis Patients
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Cognitively Relapsing Patients | 25 | 0 (0.0%) | 0 |
| Stable Multiple Sclerosis Patients | 25 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change From Baseline on the Symbol Digit Modalities Test (SDMT)
Day 0 and Day 90
Thinking and memoryTimed 25-foot Walk
Day 0 and Day 90
Disability progressionWalking and mobilityChange From Baseline on the Paced Auditory Serial Addition Test (PASAT)
Day 0 and Day 90
Thinking and memoryChange From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R)
Day 0 and Day 90
Thinking and memoryChange From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II)
Day 0 and Day 90
Thinking and memory
Other measures (4)
Change From Baseline on the Expanded Disability Status Scale (EDSS).
Day 0 and Day 90
Disability progressionChange From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
Day 0 and Day 90
Thinking and memoryChange From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS)
Day 0 and Day 90
Mood and sleepChange From Baseline on the Fatigue Severity Scale (FSS)
Day 0 and Day 90
Fatigue
Who could take part
Relapsing and progressive · 18 to 65
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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.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.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.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.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.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.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.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.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.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.
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History
Started
Aug 2013
Main results due
Nov 2018
Finished
Nov 2018
Results posted
Apr 2020
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