NCT00021697已完成3 期
A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis
Avanir Pharmaceuticals33 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2001年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 33
研究概览
简要总结
The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
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
- Double
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
- •18 to 80 years of age, inclusive
- •Confirmed diagnosis of ALS or probable ALS
- •Clinical history of pseudobulbar affect
- •If female, must not be pregnant, breast-feeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test prior to start of study
- •If female, must have been practicing an established method of birth control for at least the prior month (oral contraceptive tablets, hormonal implant device, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, tubal ligation, or abstinence) or be surgically sterile or post-menopausal
- •Must be willing to not take any prohibited medications during participation in the study
排除标准
- •Known sensitivity to quinidine or opiate drugs (codeine, etc.)
- •On any anti-depressive medication
- •Recently (within two months) diagnosed with ALS
- •Currently participating in, or who within the past 30 days have participated in, the study of another investigational new drug
- •Previously received treatment with co-administration of dextromethorphan and quinidine
- •History of substance abuse within the past two years
- •Women who are pregnant or likely to become pregnant during the course of the study
研究者
研究点 (33)
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