Multiple Sclerosis Clinical Trial
Official title:
Effects of Adrenocorticotropic Hormone (ACTHAR Gel) on Recovery From Cognitive Relapses in Multiple Sclerosis
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.
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