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

Information source: Neurologique Foundation, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Methylprednisolone (Drug); ACTH (Drug); IV placebo (Other); IM placebo (Other)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: Neurologique Foundation, Inc.

Official(s) and/or principal investigator(s):
Daniel Kantor, MD, BSE, Principal Investigator, Affiliation: Neurologique Foundation, Inc.


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).

Secondary outcome:

Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.

Safety and tolerability of ACTH and MP in patients with an acute relapse of multiple sclerosis after sub-response to an initial course of intravenous methylprednisolone.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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)

Locations and Contacts

Neurologique Foundation, Inc., Ponte Vedra, Florida 32082, United States
Additional Information

Study sponsor website

Starting date: October 2009
Last updated: September 6, 2011

Page last updated: August 23, 2015

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