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

Inclusion Criteria:

• male or female

  • females of childbearing potential must:

    • have negative pregnancy tests prior to entry into the Double-blind Treatment Phase
    • agree to use adequate contraception during the treatment.
  • females who are either post-menopausal for 12 months prior to randomization or surgically sterile (if documented), may be included without above requirements
• ≥ 18 years of age
• sign written informed consent prior to participating in the study (Appendix 1)
• willing and able to comply with trial requirements, including visit schedule and completion of scales
• diagnosis of multiple sclerosis by 2005 revised McDonald criteria (Appendix 3)
• an Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive
• currently taking a stable dose of an injectable MS disease modifying agent for the preceding 6 months or greater prior to the study-entry relapse
• in the opinion of their treating physician should undergo a 3 - 5 day course of 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)