Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

This study has been terminated.
(low enrollment)
Sponsor:
Collaborators:
National Multiple Sclerosis Society
Pfizer
Information provided by (Responsible Party):
Fred Lublin, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00418145
First received: January 2, 2007
Last updated: October 25, 2013
Last verified: October 2013
  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 3

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:


Further study details as provided by Mount Sinai School of Medicine:

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 ]

Enrollment: 17
Study Start Date: September 2003
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: megadose oral methylprednisolone
1400 mg qd/5 days
Drug: megadose oral methylprednisolone
1400 mg qd/5 days
Experimental: IV methylprednisolone
1000 mg/qd/5 days
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
The Jacobs Neurological Institute
Buffalo, New York, United States, 14203
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
St. Luke's Roosevelt
New York, New York, United States, 10019
Hospital For Joint Diseases
New York, New York, United States, 10003
Columbia University Medical Center
New York, New York, United States, 10032
NY Presbyterian Hospital-Cornell University New York
New York, New York, United States, 10065
University of Rochester
Rochester, New York, United States, 14627
United States, Vermont
University of Vermont, Burlington
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
Fred Lublin
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, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00418145     History of Changes
Other Study ID Numbers: GCO 01-0781, RG 3363A8
Study First Received: January 2, 2007
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
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 hemisuccinate
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014