Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone

Exclusion Criteria

• •a manifestation of MS other than relapsing
• •initial IV MP greater than 14 days after from start of presenting relapse
• •a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome
• •a known or 'new' diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes \[≥126 mg/dL or ≥7 mmol/L if fasting; ≥200 mg/dL or 11.1 mmol/L if random testing\] a patient should be further evaluated for diabetes mellitus)
• •a contraindication to steroid therapy, e.g., peptic ulcer, psychotic states or severe hypertension
• •sensitivity to proteins of porcine origin
• •a known or 'new' diagnosis of severe depression as defined by a score greater than 30 on the Beck Depression Inventory (BDI)
• •a known or 'new' diagnosis of hypothyroidism not adequately controlled with medication
• •treatment with Natalizumab in the past 6 months
• •active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively
• •have received total lymphoid irradiation or bone marrow transplantation
• •have been treated with corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to Pre-Randomization Phase
• •any medically unstable condition, as assessed by the primary treating physician
• •any of the following neurologic/psychiatric disorders:
• •* history of substance abuse (drug or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
• •* progressive neurological disorder, other than MS, which may affect participation in the study or require the use of medications not allowed by the protocol
• •any of the following abnormal laboratory values:
• •* serum creatinine greater than 1.7 mg/dL (150 μmol/L)
• •* white blood cell (WBC) count \<3,500/mm3 (\<3.5 X 109 / L)
• •* lymphocyte count \<800/mm3 (\<0.8 X 109 / L)