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

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)