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

NCT ID: NCT00947895

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Methylprednisolone

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

Group Type: ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type: DRUG

IV 1000 mg daily for 3 days

IM placebo

Intervention Type: OTHER

IM placebo (saline) daily for 5 days.

ACTH

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

Group Type: ACTIVE_COMPARATOR

ACTH

Intervention Type: DRUG

IM ACTH 80 mg/day for 5 days.

IV placebo

Intervention Type: OTHER

IV placebo (saline) daily for 3 days.

Interventions

Methylprednisolone

IV 1000 mg daily for 3 days

Intervention Type: DRUG

ACTH

IM ACTH 80 mg/day for 5 days.

Intervention Type: DRUG

IV placebo

IV placebo (saline) daily for 3 days.

Intervention Type: OTHER

IM placebo

IM placebo (saline) daily for 5 days.

Intervention Type: OTHER

Other Intervention Names

Solumedrol; H.P. Acthar Gel; Repository corticotropin injection; Adrenocorticotropin hormone

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: collaborator

Neurologique Foundation, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Kantor, MD

Role: PRINCIPAL_INVESTIGATOR

Neurologique Foundation, Inc.

Locations

Neurologique Foundation, Inc.

Ponte Vedra, Florida, United States

Countries

United States

Related Links

http://www.neurologique.org

Study sponsor website

Other Identifiers

Q1001

Identifier Type: -

Identifier Source: org_study_id