Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

Multiple Sclerosis Clinical Trial

Official title:

Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00418145
• Other study ID #: GCO 01-0781
• Secondary ID: RG 3363A8
• Status: Terminated
• Phase: Phase 3
• First received: January 2, 2007
• Last updated: October 25, 2013
• Start date: September 2003
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• megadose oral methylprednisolone
1400 mg qd/5 days
• IV methylprednisolone
1000 mg/qd/5 days

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York
United States	The Jacobs Neurological Institute	Buffalo	New York
United States	University of Vermont, Burlington	Burlington	Vermont
United States	University of Medicine and Dentistry of New Jersey	New Brunswick	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Hospital For Joint Diseases	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NY Presbyterian Hospital-Cornell University New York	New York	New York
United States	St. Luke's Roosevelt	New York	New York
United States	University of Rochester	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
Fred Lublin	National Multiple Sclerosis Society, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded Disability Status Scale (EDSS) mean recovery from Day 0 to Day 28.		Day 28 and Day 90	Yes
Secondary	Clinical parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) between oral and IV steroid therapy in subjects with relapsing forms of MS.		Day 28 and day 90	No
Secondary	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.		Day 28 and day 90 and day 365	Yes
Secondary	Improvement using Targeted Neurological Deficits (TND).		Day 28 and day 90	No