NCT01987167已完成早期 1 期
Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis
Neuro-Ophthalmologic Associates, PC1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Neuro-protection
研究概览
简要总结
The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
详细描述
Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral acute demyelinating optic neuritis
- •Able to provide informed consent
- •age 18 or older
- •can perform the above listed electrophysiologic diagnostic testing
- •can perform high and low contrast visual acuity and visual field perimetry
排除标准
- •prior diagnosis of remitting/relapsing multiple sclerosis(RRMS)
- •secondary progressive MS(SPMS)
- •primary progressive MS (PPMS)
- •undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination)
- •prior diagnosis of systemic lupus erythematosis
- •mixed connective tissue disease
- •vasculitis
- •sarcoidosis
- •neuro-myelitis optica
研究组 & 干预措施
-ACHTHAR
Experimental
Subcutaneous ACTHAR 5 days of 80 IU and 10 Days of 40 IU
干预措施: ACTHAR (Drug)
结局指标
主要结局
Neuro-protection
时间窗: 12 months
Functional with low contrast visual acuity in bothe the eye acutely affected by optic neuritis and the clinically unaffected eye.
次要结局
- Preservation of retinal nerve fiber layer.(12 months)
研究者
研究点 (1)
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