Effects of Acthar on Recovery From Cognitive Relapses in MS

• Status: Completed
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: State University of New York at Buffalo
• Treatments: Adrenocorticotropic Hormone; beta-Endorphin; Hormones; Melanocyte-Stimulating Hormones

Criteria

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prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to his/her future medical care.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