Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks - Full Text View

Sponsor:	Lublin, Fred D., M.D.
Collaborators:	National Multiple Sclerosis Society Pfizer
Information provided by:	Lublin, Fred D., M.D.
ClinicalTrials.gov Identifier:	NCT00418145

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: megadose oral methylprednisolone Drug: IV methylprednisolone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Lublin, Fred D., M.D.:

Primary Outcome Measures:

Expanded Disability Status Scale (EDSS) mean recovery from Day 0 to Day 28. [ Time Frame: Day 28 and Day 90 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: Day 28 and day 90 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Improvement using Targeted Neurological Deficits (TND). [ Time Frame: Day 28 and day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2003
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: megadose oral methylprednisolone 1400 mg qd/5 days
Experimental: 2	Drug: IV methylprednisolone 1000 mg/qd/5 days

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418145

Contacts

Contact: Michele Weber

212-241-4264

Michele.Weber@msnyuhealth.org

Locations

United States, New Jersey
University of Medicine and Dentistry of New Jersey	Suspended
New Brunswick, New Jersey, United States
United States, New York
Maimonides Medical Center	Suspended
Brooklyn, New York, United States
The Jacobs Neurological Institute	Suspended
Buffalo, New York, United States
Mount Sinai School of Medicine	Recruiting
New York, New York, United States, 10029
Contact: Michele Weber 212-241-4264 Michele.Weber@msnyuhealth.org
Principal Investigator: Fred Lublin, MD
Sub-Investigator: Aaron Miller, MD
St. Luke's Roosevelt	Suspended
New York, New York, United States
Hospital For Joint Diseases	Suspended
New York, New York, United States
Columbia University Medical Center	Suspended
New York, New York, United States
NY Presbyterian Hospital-Cornell University New York	Suspended
New York, New York, United States
University of Rochester	Suspended
Rochester, New York, United States
United States, Vermont
University of Vermont, Burlington	Suspended
Burlington, Vermont, United States

Sponsors and Collaborators

Lublin, Fred D., M.D.

National Multiple Sclerosis Society

Pfizer

Investigators

Principal Investigator:

Fred Lublin, MD

Mount Sinai School of Medicine

More Information

No publications provided

Responsible Party:	Fred Lublin, MD, Mount School of Medicine
ClinicalTrials.gov Identifier:	NCT00418145 History of Changes
Other Study ID Numbers:	RG 3363A8, 01-0781
Study First Received:	January 2, 2007
Last Updated:	June 14, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lublin, Fred D., M.D.:

Relapsing Forms of Multiple Sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone phosphate

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on February 09, 2012