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
  Purpose

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 Intervention Phase
Multiple Sclerosis
Drug: Methylprednisolone
Drug: ACTH
Other: IV placebo
Other: IM placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Neurologique Foundation, Inc.:

Primary Outcome Measures:
  • Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: October 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947895

Locations
United States, Florida
Neurologique Foundation, Inc.
Ponte Vedra, Florida, United States, 32082
Sponsors and Collaborators
Neurologique Foundation, Inc.
Questcor Pharmaceuticals, Inc.
Investigators
Principal Investigator: Daniel Kantor, MD, BSE Neurologique Foundation, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Neurologique Foundation, Inc.
ClinicalTrials.gov Identifier: NCT00947895     History of Changes
Other Study ID Numbers: Q1001
Study First Received: July 2, 2009
Last Updated: September 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurologique Foundation, Inc.:
ACTH
Acthar gel
adrenocorticotropin
methylprednisolone
solumedrol
MS
multiple
sclerosis
relapse
exacerbation
sub-responsive
IV

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Adrenocorticotropic Hormone
Hormones
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Beta-Endorphin
Methylprednisolone acetate
Prednisolone acetate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014