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Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
megadose oral methylprednisolone
IV methylprednisolone
Sponsored by
Fred Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Relapsing Forms of Multiple Sclerosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Medicine and Dentistry of New Jersey
  • Maimonides Medical Center
  • The Jacobs Neurological Institute
  • Hospital For Joint Diseases
  • St. Luke's Roosevelt
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center
  • NY Presbyterian Hospital-Cornell University New York
  • University of Rochester
  • University of Vermont, Burlington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

megadose oral methylprednisolone

IV methylprednisolone

Arm Description

1400 mg qd/5 days

1000 mg/qd/5 days

Outcomes

Primary Outcome Measures

Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
There is no data analysis for this study

Secondary Outcome Measures

Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.
Frequency of Relapse Over Time (up to One Year) When Subjects With Relapsing Forms of MS Are Administered One Course of Oral Methylprednisolone Compared to IV Administration.
Improvement Using Targeted Neurological Deficits (TND).

Full Information

First Posted
January 2, 2007
Last Updated
April 10, 2017
Sponsor
Fred Lublin
Collaborators
National Multiple Sclerosis Society, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00418145
Brief Title
Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks
Official Title
Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
low enrollment - data was not analyzed for this study
Study Start Date
September 2003 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fred Lublin
Collaborators
National Multiple Sclerosis Society, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Relapsing Forms of Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
megadose oral methylprednisolone
Arm Type
Experimental
Arm Description
1400 mg qd/5 days
Arm Title
IV methylprednisolone
Arm Type
Experimental
Arm Description
1000 mg/qd/5 days
Intervention Type
Drug
Intervention Name(s)
megadose oral methylprednisolone
Intervention Description
1400 mg qd/5 days
Intervention Type
Drug
Intervention Name(s)
IV methylprednisolone
Intervention Description
1000 mg/qd/5 days
Primary Outcome Measure Information:
Title
Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
Description
There is no data analysis for this study
Time Frame
Day 28 and Day 90
Secondary Outcome Measure Information:
Title
Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.
Time Frame
Day 28 and day 90
Title
Frequency of Relapse Over Time (up to One Year) When Subjects With Relapsing Forms of MS Are Administered One Course of Oral Methylprednisolone Compared to IV Administration.
Time Frame
Day 28 and day 90 and day 365
Title
Improvement Using Targeted Neurological Deficits (TND).
Time Frame
Day 28 and day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Lublin, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Dentistry of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
The Jacobs Neurological Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Hospital For Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
St. Luke's Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
NY Presbyterian Hospital-Cornell University New York
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
University of Vermont, Burlington
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States

12. IPD Sharing Statement

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Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

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