Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks

NCT00418145

Last updated date
Study Location
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08901, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks
Official Title  ICMJE Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: megadose oral methylprednisolone
    1400 mg qd/5 days
  • Drug: IV methylprednisolone
    1000 mg/qd/5 days
Study Arms  ICMJE
  • Experimental: megadose oral methylprednisolone
    1400 mg qd/5 days
    Intervention: Drug: megadose oral methylprednisolone
  • Experimental: IV methylprednisolone
    1000 mg/qd/5 days
    Intervention: Drug: IV methylprednisolone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
16
Original Enrollment  ICMJE
 (submitted: January 3, 2007)
120
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00418145
Other Study ID Numbers  ICMJE GCO 01-0781
RG 3363A8
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fred Lublin, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Fred Lublin
Collaborators  ICMJE
  • National Multiple Sclerosis Society
  • Pfizer
Investigators  ICMJE
Principal Investigator:Fred Lublin, MDIcahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP