Effects of Acthar on Recovery From Cognitive Relapses in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Adrenocorticotropic Hormone
Intervention description: Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute Relapsing Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive

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.
    

Eligibility 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.