Clinical trial NCT00418145: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Relapsing Forms of Multiple Sclerosis
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: Pfizer
First posted: 2007-01-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
timeFrame: Day 28 and Day 90
Secondary outcomes:
measure: Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.
timeFrame: Day 28 and day 90
measure: 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.
timeFrame: Day 28 and day 90 and day 365
measure: Improvement Using Targeted Neurological Deficits (TND).
timeFrame: Day 28 and day 90
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: The Jacobs Neurological Institute
state: New York
city: New York
country: United States
facility: Hospital For Joint Diseases
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: NY Presbyterian Hospital-Cornell University New York
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Burlington
country: United States
facility: University of Vermont, Burlington
state: Vermont
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Fred Lublin, MD
role: PRINCIPAL_INVESTIGATOR
References: