Efficacy Study of Adrenocorticotropin Hormone to Treat Multiple Sclerosis (MS) Relapses After Sub-responding to an Initial 3 Day Course of Intravenous (IV) Methylprednisolone
Relative Efficacy of Repeat Course of Intravenous methyLprednisolone and Intramuscular ACTH in the Treatment of Acute Relapse of Multiple Sclerosis After Sub Response to Initial Course of Intravenous Methylprednisolone (RECLAIM): a Single Center Pilot Study
  • Phase

    Phase 2/Phase 3
  • Study Type

  • Status

  • Study Participants

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.
Study Started
Oct 31
Primary Completion
Jan 31
Study Completion
Jan 31
Last Update
Mar 22

Drug Methylprednisolone

IV 1000 mg daily for 3 days

  • Other names: Solumedrol


IM ACTH 80 mg/day for 5 days.

  • Other names: H.P. Acthar Gel, Repository corticotropin injection, Adrenocorticotropin hormone

Other IV placebo

IV placebo (saline) daily for 3 days.

Other IM placebo

IM placebo (saline) daily for 5 days.

Methylprednisolone Active Comparator

Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days.

ACTH Active Comparator

Intramuscular (IM) ACTH 80 mg/day for 5 days.


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)
No Results Posted