Effects of Acthar on Recovery From Cognitive Relapses in MS
Effects of Acthar on Recovery From Cognitive Relapses in MS
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.
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-month follow-up. Comparison will be made to a stable MS control
 group.

 The objectives of the study are:

 1. To replicate prior findings with steroid therapy for MS patients for cognitive relapses,
 using instead Acthar Gel as the treating agent. The investigators will determine if the
 decrease on cognitive endpoints at the time of relapse exceeds that of stable MS
 controls.

 2. To compare the effects above to a previously acquired dataset of relapsing patients
 treated with steroids. This is a quasi-experimental design in so far as the steroid
 treated group data were previously acquired in a separate study.

 The primary hypothesis of the study is that, due to the enhanced melanocortin response in
 Acthar the recovery from cognitive changes occurring during cognitively focused relapse will
 be significant compared to stable MS patients matched on age, time since testing, and
 cognitive performance on the SDMT.

 Target enrollment for the Acthar treatment group will be 30 MS patients under care at the
 Jacobs Neurological Institute with existing neuropsychological baseline in the past four
 years in whom a cognitive relapse or new supratentorial GAD enhancing lesion(s) on MRI have
 been identified. Cognitive relapse will be identified based on clinical presentation of acute
 worsening of cognitive symptoms in the domains of processing speed, concentration, episodic
 memory, working memory, and/or fatigue. Patients whose clinical MRI indicate new active GAD
 enhancing lesions will be screened for the presence of self-perceived cognitive decline,
 without new physical symptoms. Thirty (30) clinically stable MS patients matched on age, time
 since testing, and cognitive performance on the SDMT will be recruited from the pool of
 patients with existing cognitive baselines.
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.