Safety and Tolerability of ISX (Isoxsuprine HCL) in MS Relapses

Exclusion Criteria

• •1\. Subject is from a vulnerable population, as defined by the US CFR Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the IRB.
• •2\. Subject has only sensory, bowel/bladder, and/or cognitive symptoms of MS associated with the most recent relapse.
• •3\. Subject has cognitive or behavioral impairment that in the opinion of the investigator would impair the ability of the subject to comply with study procedures.
• •4\. Subject has any known contraindication(s) to the use of corticosteroids or isoxsuprine hydrochloride (ISX), including, but not limited to:
• •* any current uncontrolled hypertension, primary adrenocortical insufficiency
• •* Any current psychoses, infectious disease, or Cushing's syndrome.
• •* Any current congestive heart failure (defined as New York Heart Association (Functional Class III to IV).
• •* Peptic ulcer (within 24 weeks prior to the Screening Visit).
• •* Recent major surgery (within 24 weeks prior to the Screening Visit).
• •* Use of tizanidine any time in the past 30 days. 5. Subject has a clinically significant infection requiring intravenous administration of antibiotics and hospitalization prior to the Screening Visit.
• •6\. Subject has poorly controlled type 1 or type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not exclusionary 7. Received systemic steroids for a problem unrelated to the MS relapse within 30 days prior to screening.
• •8\. History of other neurological disease that, 'in the opinion of the Investigator, would affect motor function or cognition; 9. For patients with a history of Major Depressive Disorder, at risk for worsening depression due to steroids or the presence of active depressive symptoms sufficient, in the opinion of the investigator, to affect the subject's ability to complete study assessments, or which would not be in the subject's best Interest to participate in the study; 10. Presence of cognitive impairment sufficient, in the opinion of the investigator, to affect the subject's ability to complete study assessments, or which would not be In the subject's best interest to participate in the study 11. History of sensory impairments (e.g., hearing, vision) that, In the opinion of the investigator, would impair the subject's ability to complete study assessments; 12. History of current alcohol or substance abuse or dependence; 13. History of myocardial infarction, or NYHA Functional Classification of Heart Failure Class 3 or 4 within 2 years prior to screening, or history of coronary artery disease and/or active angina pectoris; 14. Any clinically significant ECG abnormalities;; 15. Inability to swallow oral capsules, or a history of gastrointestinal malabsorption that would preclude the use of oral medication; 16. If female, is pregnant or lactating; 17. History of hypersensitivity or allergic reaction to any of the study drugs. 18. History of heavy use of tobacco/smoking