Multiple Sclerosis
Conditions
Keywords
Relapsing Forms of Multiple Sclerosis
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.
Interventions
DRUGmegadose oral methylprednisolone
1400 mg qd/5 days
1000 mg/qd/5 days
Sponsors
National Multiple Sclerosis Society
Pfizer
Fred Lublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28. | Day 28 and Day 90 | There is no data analysis for this study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Improvement Using Targeted Neurological Deficits (TND). | Day 28 and day 90 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Study Participants Overall study participants - Data not available separated by arm. Data is also no longer accessible. Data was with biostatistician who no longer has data. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | study terminated | 6 |
Baseline characteristics
| Characteristic | Total Study Participants |
|---|---|
| Age, Customized age 18-29 | 6 participants |
| Age, Customized age 30-39 | 3 participants |
| Age, Customized age 40-49 | 7 participants |
| Age, Customized age 50+ | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
There is no data analysis for this study
Time frame: Day 28 and Day 90
Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.
Secondary
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
Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.
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.
Time frame: Day 28 and day 90 and day 365
Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.
Secondary
Improvement Using Targeted Neurological Deficits (TND).
Time frame: Day 28 and day 90
Population: Data is also no longer accessible. Data was with biostatistician who no longer has data.