临床试验/NCT00661440

NCT00661440已完成2 期

Efficacy and Safety of Neramexane Mesylate in Congenital Idiopathic Nystagmus and Acquired Nystagmus: a Randomized, Double-blind, Placebo-controlled, Single Center, Proof of Concept Study Using a Two-period Cross-over Design

Merz Pharmaceuticals GmbH1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2008年5月最近更新: 2009年11月26日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Merz Pharmaceuticals GmbH
入组人数: 48
试验地点: 1
主要终点: Visual acuity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of congenital idiopathic nystagmus (CIN) in comparison to placebo. In addition, a subgroup of multiple sclerosis (MS) patients suffering from acquired nystagmus will be included; this subgroup will be analyzed in an exploratory manner only.

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: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•patients with congenital idiopathic nystagmus or acquired nystagmus subsequent to multiple sclerosis
•male or female outpatients
•aged between 18 and 80 years (inclusive) at screening

排除标准

•patients with evidence of neurologic disorders other than CIN such as congenital nystagmus due to albinism or retinal diseases and/or acquired nystagmus (exemption: secondary to MS)

研究组 & 干预措施

1

Other

干预措施: Neramexane mesylate (Drug)

2

Other

干预措施: Neramexane mesylate (Drug)

结局指标

主要结局

Visual acuity

时间窗: Screening, Baseline, Week 3, 7, 11, 14, 18, and Follow-up

次要结局

nystagmus intensity, expanded nystagmus acuity function, reading ability, questionnaires, safety parameter

研究者

发起方

Merz Pharmaceuticals GmbH

申办方类型

Industry

研究点 (1)

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