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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)

This study has been terminated.
(Study reached halfway point in approximately one year time period and was halted to analyze data.)
Sponsor:
Collaborator:
Questcor Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Neurologique Foundation, Inc.
ClinicalTrials.gov Identifier:
NCT00947895
First received: July 2, 2009
Last updated: September 6, 2011
Last verified: September 2011

July 2, 2009
September 6, 2011
October 2009
January 2011   (final data collection date for primary outcome measure)
Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00947895 on ClinicalTrials.gov Archive Site
  • Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Methylprednisolone
    IV 1000 mg daily for 3 days
    Other Name: Solumedrol
  • 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.
  • Other: IM placebo
    IM placebo (saline) daily for 5 days.
  • Active Comparator: Methylprednisolone
    Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days.
    Interventions:
    • Drug: Methylprednisolone
    • Other: IM placebo
  • Active Comparator: ACTH
    Intramuscular (IM) ACTH 80 mg/day for 5 days.
    Interventions:
    • Drug: ACTH
    • Other: IV placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
January 2011
January 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947895
Q1001
No
Neurologique Foundation, Inc.
Neurologique Foundation, Inc.
Questcor Pharmaceuticals, Inc.
Principal Investigator: Daniel Kantor, MD, BSE Neurologique Foundation, Inc.
Neurologique Foundation, Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP