RECLAIM

Treatment tested

• Methylprednisolone

  Glucocorticoid receptor agonist

• Corticotropin

  Melanocortin receptor 2 agonist

Placebo or sham

• IV placebo
• IM placebo

Other measures (2)

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)

The purpose of this study is to compare intramuscular (IM) ACTH (adrenocorticotropin hormone) and intravenous (IV) methylprednisolone (Solumedrol) for the treatment of an MS (Multiple Sclerosis) relapse (exacerbation) after sub-response to an initial 3 day course of IV methylprednisolone.