Effects of Acthar on Recovery From Cognitive Relapses in MS

Completed · Phase 3

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT02290444

Run by

State University of New York at Buffalo

People needed

64

Starts

2013-08-01

Expected to finish

2018-11-01

Last updated by the study team

2020-04-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.

You may not qualify if…

• 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.

Where it is running

• University at Buffalo-State University of New York, Department of Neurology, Buffalo General Hospital — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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