A Double-blind, Placebo-controlled, Randomized Crossover, Activity Study of Single Oral Doses of 50 mg and 400 mg Nerispirdine on Visual Function in Patients With Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Visual Evoked Potential (P100) latency
研究概览
简要总结
The primary objective of the study was to evaluate the effect of Nerispirdine (50 mg or 400 mg) and placebo given orally as a single dose once a week in crossover design on latency of Visual Evoked Potentials (VEP) P100 in optic nerves.
Secondary objectives included evaluation of the effect of Nerispirdine on VEP amplitude and other visual parameters including visual acuity and contrast, as well as evaluation of the safety and tolerability of Nerispirdine in patients with Multiple Sclerosis (MS).
Contrast sensitivity and visual acuity examinations (in addition to Optical Coherence Tomography [OCT] and VEPs) were needed during the screening period for defining etiologic relationships (if non-MS related impairment) and for assessing the effect of treatment of age-related eye disease versus the MS-related vision impairment.
详细描述
The crossover design included 3 treatment periods 1 week apart and 6 treatment sequences. Study participation were to be 5 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically definite MS (McDonald criteria), which includes patients with remitting-relapsing, secondary progressive, progressive-relapsing, or primary progressive MS who have had a past history of Optic Neuritis.
排除标准
- •Multiple sclerosis exacerbation within 60 days of the Screening Visit and the relapse involved the visual fields or visual acuity
- •No eye with appropriate degree of lesions for this study as defined by criteria based on degree of visual acuity deficit, refractive error, VEP P100 latency and average retinal nerve fiber layer thickness of as measured by Optical Coherence Tomography (OCT)
- •Any MS-unrelated prior ophthalmological impairment (eg, compressive, ischemic, toxic, or nutritional optic neuropathies, Leber's hereditary optic atrophy)
- •Previously exposed to 3,4-diaminopyridine or 4-aminopyridine
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Sequence 6
400 mg Nerispirdine, 1 day treatment period 1
50 mg Nerispirdine, 1 day treatment period 2
placebo, 1 day treatment period 3
干预措施: Placebo (Drug)
Sequence 1
placebo,1 day treatment period 1
50 mg Nerispirdine, 1 day treatment period 2
400 mg Nerispirdine, 1 day treatment period 3
干预措施: Placebo (Drug)
Sequence 2
placebo,1 day treatment period 1
400 mg Nerispirdine, 1 day treatment period 2
50 mg Nerispirdine, 1 day treatment period 3
干预措施: Placebo (Drug)
Sequence 5
400 mg Nerispirdine, 1 day treatment period 1
placebo, 1 day treatment period 2
50 mg Nerispirdine, 1 day treatment period 3
干预措施: Placebo (Drug)
Sequence 3
50 mg Nerispirdine, 1 day treatment period 1
placebo, 1 day treatment period 2
400 mg Nerispirdine, 1 day treatment period 3
干预措施: Placebo (Drug)
Sequence 4
50 mg Nerispirdine, 1 day treatment period 1
400 mg Nerispirdine, 1 day treatment period 2
placebo, 1 day treatment period 3
干预措施: Placebo (Drug)
Sequence 2
placebo,1 day treatment period 1
400 mg Nerispirdine, 1 day treatment period 2
50 mg Nerispirdine, 1 day treatment period 3
干预措施: Nerispirdine (Drug)
Sequence 1
placebo,1 day treatment period 1
50 mg Nerispirdine, 1 day treatment period 2
400 mg Nerispirdine, 1 day treatment period 3
干预措施: Nerispirdine (Drug)
Sequence 3
50 mg Nerispirdine, 1 day treatment period 1
placebo, 1 day treatment period 2
400 mg Nerispirdine, 1 day treatment period 3
干预措施: Nerispirdine (Drug)
Sequence 4
50 mg Nerispirdine, 1 day treatment period 1
400 mg Nerispirdine, 1 day treatment period 2
placebo, 1 day treatment period 3
干预措施: Nerispirdine (Drug)
Sequence 5
400 mg Nerispirdine, 1 day treatment period 1
placebo, 1 day treatment period 2
50 mg Nerispirdine, 1 day treatment period 3
干预措施: Nerispirdine (Drug)
Sequence 6
400 mg Nerispirdine, 1 day treatment period 1
50 mg Nerispirdine, 1 day treatment period 2
placebo, 1 day treatment period 3
干预措施: Nerispirdine (Drug)
结局指标
主要结局
Visual Evoked Potential (P100) latency
时间窗: pre-dose and post-dose of each treatment intake (3)
次要结局
- Pelli-Robson Contrast Sensitivity Score(pre-dose and post-dose of each treatment intake (3))
- Early Treatment Diabetic Retinopathy Study (EDTRS) visual acuity score(pre-dose and post-dose of each treatment intake (3))
- Visual Evoked Potential (VEP) amplitude(pre-dose and post-dose of each treatment intake (3))