NCT00314912Unknown3 期
An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease
Bellus Health Inc. - a GSK company1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- To evaluate the long-term safety of Tramiprosate (3APS).
研究概览
简要总结
The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer's disease.
详细描述
Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study.
- •Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).
- •Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.
- •The patient must be presenting a reasonably good nutritional status.
- •Signed inform consent from the patient or legal representative.
排除标准
- •Patients will not be eligible to participate in the study if they meet any of the following criteria:
- •The patient participates in another drug trial during the study.
- •The patient with a clinically significant and/or uncontrolled condition or other significant medical disease.
- •The patient is unable to swallow medication tablets.
结局指标
主要结局
To evaluate the long-term safety of Tramiprosate (3APS).
次要结局
- To provide additional long-term data on the efficacy of Tramiprosate (3APS).
研究者
研究点 (1)
Loading locations...
相似试验
招募中
3 期
A Long-Term Study of JNT-517 in Participants With PhenylketonuriaPhenylketonuria (PKU)NCT06628128Otsuka Pharmaceutical Development & Commercialization, Inc.240
进行中（未招募）
3 期
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary DiseaseNCT05878769Hoffmann-La Roche2,000
已完成
3 期
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple SclerosisMultiple SclerosisNCT00654927Acorda Therapeutics177
已完成
3 期
An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMDGeographic Atrophy Secondary to Age-related Macular DegenerationNCT04770545Apellis Pharmaceuticals, Inc.792
已完成
3 期
An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseNCT00505687UCB Pharma186