Status:
COMPLETED
Effects of Acthar on Recovery From Cognitive Relapses in MS
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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-mo...
Eligibility Criteria
Inclusion
- 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02290444
Start Date
August 1 2013
End Date
November 1 2018
Last Update
April 6 2020
Active Locations (1)
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1
University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital
Buffalo, New York, United States, 14203