Effects of Acthar on Recovery From Cognitive Relapses in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Adrenocorticotropic Hormone
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): Acthar gel
Intervention MeSH terms: Hormones; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Acute Relapsing Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive