Phase 3
Completed N=64
Effects of Acthar on Recovery From Cognitive Relapses in MS
Source: ClinicalTrials.gov NCT02290444 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Change From Baseline on the Symbol Digit Modalities Test (SDMT) — 44.6; 58.5 Total Correct
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the Symbol Digit Modalities Test (SDMT) |
44.6; 58.5 | — |
| PRIMARY Timed 25-foot Walk |
6.7; 5.3 | — |
| PRIMARY Change From Baseline on the Paced Auditory Serial Addition Test (PASAT) |
40.1; 47.0 | — |
| PRIMARY Change From Baseline on the Brief Visuospatial Memory Test-Revised (BVMT-R) |
22.0; 22.5 | — |
| PRIMARY Change From Baseline on the California Verbal Learning Test, Second Edition (CVLT-II) |
46.6; 51.2 | — |
| SECONDARY Change From Baseline on the Expanded Disability Status Scale (EDSS). |
3.0; 2.0 | — |
| SECONDARY Change From Baseline on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ) |
34.5; 20.0 | — |
| SECONDARY Change From Baseline on the Beck Depression Inventory-Fast Screen (BDI-FS) |
5.0; 1.6 | — |
| SECONDARY Change From Baseline on the Fatigue Severity Scale (FSS) |
5.4; 3.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02290444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.