efficacy study of adrenocorticotropin hormone to treat multiple sclerosis (ms) relapses after sub-responding to an initial 3 day course of intravenous (iv) methylprednisolone

Conditions: Multiple Sclerosis

Summary: 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.


Eligibility criteria:
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)

Keywords: acth acthar gel adrenocorticotropin methylprednisolone solumedrol ms multiple sclerosis relapse exacerbation sub-responsive iv