NCT00982150终止2 期
A Multinational, Multicenter, Open Label Phase to Assess Tolerability and Safety of Talampanel 50mg Tid in Subjects With Amyotrophic Lateral Sclerosis (ALS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 446
- 主要终点
- ALSFRS-R
研究概览
简要总结
This will be an open label treatment extension phase in patients with ALS who have previously participated in the double blind, placebo-controlled ALS-TAL-201 study. This study will make talampanel treatment available to all subjects who completed the double blind placebo-controlled phase of ALS-TAL-201 study and where the investigator and patient consider it to be in the patient's interest to receive talampanel 50mg three times daily (tid). It will also enable the exploration of long-term safety and tolerability of talampanel 50mg tid.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have completed 52 weeks of treatment of the double blind placebo-controlled phase of ALS-TAL-
- •Women must be postmenopausal, surgically sterile, or using adequate birth control methods.
- •Patients must be willing and able to give written informed consent prior to performing any open-label study procedures.
排除标准
- •Patients with ECG signs of Brugada syndrome and/ or complete or incomplete Right Bundle Branch Block
- •Patients using any of the following:
- •Chronic use of lithium carbonate
- •Chronic use of mecasermin (rhIGF-1)
- •Chronic use of minocycline
- •Chronic use of more than 600mg/day coenzyme Q10
- •Chronic use of any marketed drug, if its use was not clearly indicated for any underlying medical condition other than ALS (symptomatic drugs for ALS and supplements allowed)
- •Patients participating in any other investigational drug study and use of any other investigational drug
- •Patients taking drugs that may interact with Talampanel
- •Females who are pregnant or nursing.
- •Females of child-bearing potential who do not practice medically acceptable methods of contraception.
- •Any condition of the patient which the investigator feels may interfere with participation in the study.
研究组 & 干预措施
Talampanel
Experimental
Talampanel 50mg tid
干预措施: Talampanel (Drug)
结局指标
主要结局
ALSFRS-R
时间窗: every 4 weeks
次要结局
- Vital Signs, ECG, Adverse Event Reports(every 26 weeks)
研究者
相似试验
Approved For Marketing
不适用
An Open-Label, Multi-Center, Expanded Access Program With Eribulin for the Treatment of Advanced Breast Cancer RefractoryMetastatic Breast CancerNCT01240421Eisai Inc.
已完成
2 期
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's DiseaseCrohn's Disease (CD)NCT02782663AbbVie107
招募中
3 期
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)Psychosis Associated With Alzheimer's DiseaseNCT05980949Karuna Therapeutics, Inc., a Bristol Myers Squibb company1,000
Approved For Marketing
不适用
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast CancerMetastatic Breast CancerNCT02792725Eli Lilly and Company
已完成
2 期
A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer's Disease Treated With CrenezumabAlzheimer's DiseaseNCT01723826Genentech, Inc.360