Multiple SclerosisPhase 3NCT00418145
Study to Evaluate Intravenous and Oral Steroids for Multiple Sclerosis Attacks
A Phase 3 study testing megadose oral methylprednisolone and IV methylprednisolone in people with Multiple Sclerosis, run by Fred Lublin at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- megadose oral methylprednisolone and IV methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2003to Oct 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Maimonides Medical Center
Brooklyn, New York, 11219
The Jacobs Neurological Institute
Buffalo, New York, 14203
University of Vermont, Burlington
Burlington, Vermont, 05405
University of Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, 08901
Hospital For Joint Diseases
New York, New York, 10003
St. Luke's Roosevelt
New York, New York, 10019
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
NY Presbyterian Hospital-Cornell University New York
New York, New York, 10065
University of Rochester
Rochester, New York, 14627
About this study
Official title: Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- megadose oral methylprednisolone, IV methylprednisolone
- Keywords
- Relapsing Forms of Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
megadose oral methylprednisoloneDrug
1400 mg qd/5 days
IV methylprednisoloneDrug
1000 mg/qd/5 days
| Study group | Role | What they receive |
|---|---|---|
| megadose oral methylprednisolone | Experimental | 1400 mg qd/5 days Receives: Drug: megadose oral methylprednisolone |
| IV methylprednisolone | Experimental | 1000 mg/qd/5 days Receives: Drug: IV methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
There is no data analysis for this study
Measured: Day 28 and Day 90
Secondary outcomes (3)
Clinical Parameters of the Multiple Sclerosis Functional Composite Scale (MSFC) Between Oral and IV Steroid Therapy in Subjects With Relapsing Forms of MS.
Measured: Day 28 and day 90
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.
Measured: Day 28 and day 90 and day 365
Improvement Using Targeted Neurological Deficits (TND).
Measured: Day 28 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startSep 2003
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: low enrollment - data was not analyzed for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Pfizer
- Responsible party
- Sponsor-investigator, Fred Lublin, Icahn School of Medicine at Mount Sinai
- Investigators
- Fred Lublin, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418145
- Sponsor's protocol ID
- GCO 01-0781
- Other IDs
- RG 3363A8
- Status last verified
- Apr 2017
- First submitted
- 2 Jan 2007
- Last updated
- 18 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)
- ClinicalTrials.gov ID
- NCT00418145
- Acronym / sponsor ID
- GCO 01-0781
- Conditions
- Multiple Sclerosis
- Keywords
- Relapsing Forms of Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment - data was not analyzed for this study
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fred LublinUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society, Pfizer
- Study start
- Sep 2003
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Jan 2007 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| megadose oral methylprednisolone | Experimental | Drug: megadose oral methylprednisolone1400 mg qd/5 days |
| IV methylprednisolone | Experimental | Drug: IV methylprednisolone1000 mg/qd/5 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| megadose oral methylprednisolone1400 mg qd/5 days | Drug | megadose oral methylprednisolone |
| IV methylprednisolone1000 mg/qd/5 days | Drug | IV methylprednisolone |
Primary outcome
Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
Time frame: Day 28 and Day 90
There is no data analysis for this study
3 secondary outcomes
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
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
Improvement Using Targeted Neurological Deficits (TND).
Time frame: Day 28 and day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred Lublin, MD principal investigator
Icahn School of Medicine at Mount Sinai
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing megadose oral methylprednisolone and IV methylprednisolone in people with Multiple Sclerosis, run by Fred Lublin at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28. (time frame: Day 28 and Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017.