Oral Megadose Corticosteroid Therapy of Acute Exacerbations of Multiple Sclerosis (OMEGA)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 10
- 主要终点
- Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
megadose oral methylprednisolone
1400 mg qd/5 days
干预措施: megadose oral methylprednisolone (Drug)
IV methylprednisolone
1000 mg/qd/5 days
干预措施: IV methylprednisolone (Drug)
结局指标
主要结局
Expanded Disability Status Scale (EDSS) Mean Recovery From Day 0 to Day 28.
时间窗: Day 28 and Day 90
There is no data analysis for this study
次要结局
- 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)
研究者
Fred Lublin
Principal Investigator
Icahn School of Medicine at Mount Sinai