Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2013-10-31

Brief Summary

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This clinical trial compares the relative efficacy of treating acute exacerbations of relapsing forms of Multiple Sclerosis with equivalent doses of oral and intravenous (IV) methylprednisolone. This is a randomized, blinded, multi-center study.

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Detailed Description

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Intravenous methylprednisolone has been the standard of care for treating acute MS flares. However, the IV administration is cumbersome, inconvenient and expensive. A true comparison of these different approaches has not been undertaken in rigorous fashion. Prior studies have demonstrated the safety of such high doses of oral steroid. For this proposal we employ equivalent oral dosing (1400 mg/day) and compare that to 1000 mg/day IV therapy in patients seen within seven days of an acute exacerbation of MS.

In addition, there are 2 arms to this double-blind, placebo controlled, randomized trial. One arm has an active IV and an oral placebo while the second arm has an IV placebo and an active oral dose. Therefore, each subject will receive an active treatment.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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megadose oral methylprednisolone

1400 mg qd/5 days

Group Type EXPERIMENTAL

megadose oral methylprednisolone

Intervention Type DRUG

1400 mg qd/5 days

IV methylprednisolone

1000 mg/qd/5 days

Group Type EXPERIMENTAL

IV methylprednisolone

Intervention Type DRUG

1000 mg/qd/5 days

Interventions

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megadose oral methylprednisolone

1400 mg qd/5 days

Intervention Type DRUG

IV methylprednisolone

1000 mg/qd/5 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 18 and 50 years, inclusive.
* Acute symptomatic exacerbation of MS present for great than 24 hours and less than or equal to 7 days at entry with new or worsening symptoms, and with signs referable to the symptoms; in the absence of a fever or active infection.
* Diagnosis of a relapsing form of multiple sclerosis before randomization as determined by Poser or McDonald Criteria.
* Expanded disability status scale (EDSS) score between 2 and 6.5, inclusive at entry.
* Episodes include study neurologist or neuro-ophthalmologist diagnosed: acute optic neuritis, cerebellar, brainstem dysfunction, myelitis, focal cerebral, and/or definitive focal sensory dysfunction.
* New objective clinical finding other than a sensory exacerbation, or bowel/bladder signs alone. Sensory deficits alone will not qualify except for optic neuritis.
* Subjects may continue on their current immunomodulating therapy (such as interferons or glatiramer acetate) throughout the course of the study. Women who become pregnant after the 5-day treatment of steroids should discontinue immunomodulatory treatment.
* Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.

Exclusion Criteria

* Any patients treated with systemic corticosteroid use within one month of the index episode at screening.
* Prior use of immunosuppressive treatments within 90 days of index episode (mitoxantrone, azathioprine, IVIg) or plasmapheresis.
* Any patient who is pregnant or breastfeeding.
* Unable to perform the Multiple Sclerosis Functional Composite consisting of: Timed 25-Foot Walk, 9-Hole Peg Test, and Paced Auditory Serial Addition Test (3 second).
* Peripheral or cranial neuropathy as sole problem of acute episode.
* History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude corticosteroid therapy.
* Primary Progressive Multiple Sclerosis (PPMS).
* Previous participation in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Fred Lublin

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fred Lublin, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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University of Medicine and Dentistry of New Jersey

New Brunswick, New Jersey, United States

Site Status

Maimonides Medical Center

Brooklyn, New York, United States

Site Status