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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 (RECLAIM)

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ClinicalTrials.gov Identifier: NCT00947895
Recruitment Status : Terminated (Study reached halfway point in approximately one year time period and was halted to analyze data.)
First Posted : July 28, 2009
Last Update Posted : March 22, 2016
Information provided by (Responsible Party):
Neurologique Foundation, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Methylprednisolone Drug: ACTH Other: IV placebo Other: IM placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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 Name: 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.

Primary Outcome Measures :
  1. Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities). [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components. [ Time Frame: 12 weeks ]
  2. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947895

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United States, Florida
Neurologique Foundation, Inc.
Ponte Vedra, Florida, United States, 32082
Sponsors and Collaborators
Neurologique Foundation, Inc.
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Principal Investigator: Daniel Kantor, MD Neurologique Foundation, Inc.
Additional Information:
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Responsible Party: Neurologique Foundation, Inc.
ClinicalTrials.gov Identifier: NCT00947895    
Other Study ID Numbers: Q1001
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Keywords provided by Neurologique Foundation, Inc.:
Acthar gel
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Adrenocorticotropic Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents