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

March 21, 2016 updated by: Neurologique Foundation, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Ponte Vedra, Florida, United States, 32082
        • Neurologique Foundation, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Methylprednisolone
Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days.
Drug: Methylprednisolone
IV 1000 mg daily for 3 days
Other Names:
  • Solumedrol
Other: IM placebo
IM placebo (saline) daily for 5 days.
ACTIVE_COMPARATOR: ACTH
Intramuscular (IM) ACTH 80 mg/day for 5 days.
Drug: ACTH
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.
Time Frame: 12 weeks
12 weeks
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.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurologique Foundation, Inc.

Collaborators

Mallinckrodt

Investigators

  • Principal Investigator: Daniel Kantor, MD, Neurologique Foundation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (ESTIMATE)

July 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Q1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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