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)

• ClinicalTrials.gov Identifier: NCT00947895
• Recruitment Status: Terminated
• First Posted: July 28, 2009
• Last Update Posted: March 22, 2016
• Sponsor: Neurologique Foundation, Inc.
• Collaborator: Mallinckrodt
• Information provided by (Responsible Party): Neurologique Foundation, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Florida

Neurologique Foundation, Inc.

Ponte Vedra, Florida, United States, 32082

Sponsors and Collaborators

Neurologique Foundation, Inc.

Mallinckrodt

Investigators

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

More Information

Additional Information:

Study sponsor website 

• Responsible Party: Neurologique Foundation, Inc.
• ClinicalTrials.gov Identifier: NCT00947895
• Other Study ID Numbers: Q1001
• First Posted: July 28, 2009
• Last Update Posted: March 22, 2016
• Last Verified: March 2016

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; Recurrence; 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; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Adrenocorticotropic Hormone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Neuroprotective Agents; Protective Agents