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

NCT00947895 | Terminated Phase 2

• 1 other identifier: Q1001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

ACTH; Acthar gel; adrenocorticotropin; methylprednisolone; solumedrol; MS; multiple; sclerosis; relapse; exacerbation; sub-responsive; IV

Outcome Measures

Primary Outcomes (1)

• Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).

  12 weeks

Secondary Outcomes (2)

• Improvement in MSFC (Multiple Sclerosis Functional Composite)18 and its three individual components.

  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.

  12 weeks

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

Intravenous (IV) methylprednisolone (Solumedrol) 1000 mg daily for 3 days.

Drug: Methylprednisolone; Other: IM placebo

ACTH

ACTIVE COMPARATOR

Intramuscular (IM) ACTH 80 mg/day for 5 days.

Drug: ACTH; Other: IV placebo

Interventions

Methylprednisolone DRUG

IV 1000 mg daily for 3 days

Also known as: Solumedrol

Methylprednisolone

ACTH DRUG

IM ACTH 80 mg/day for 5 days.

Also known as: H.P. Acthar Gel, Repository corticotropin injection, Adrenocorticotropin hormone

ACTH

IV placebo OTHER

IV placebo (saline) daily for 3 days.

ACTH

IM placebo OTHER

IM placebo (saline) daily for 5 days.

Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Neurologique Foundation, Inc.: lead
• Mallinckrodt: collaborator

Study Sites (1)

Neurologique Foundation, Inc.

Ponte Vedra, Florida, 32082, United States

Location

Related Links

• Study sponsor website

MeSH Terms

Conditions

Multiple Sclerosis; Sclerosis; Recurrence

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate; Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Daniel Kantor, MD

  Neurologique Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 28, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (1)