NCT00072709已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group, Multicenter, Dose-Ranging Study Evaluating Four Oral Doses of TCH346 (1.0, 2.5, 7.5 and 15 mg) Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 551
- 试验地点
- 11
- 主要终点
- Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
研究概览
简要总结
This is a global multicenter study designed to evaluate the safety and clinical effects of 4 oral doses of TCH346 (1.0, 2.5, 7.5, and 15 mg) compared to placebo in patients with mild or mild to moderate stages of ALS. The study consists of 3 phases: screening (up to 2 weeks), run-in (16 weeks), and a double-blind treatment phase of variable duration (at least 24 weeks).
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of laboratory-supported probable, probable, or definite ALS;
- •sporadic or familial ALS;
- •ALS symptom onset for no more than 3 yrs at study entry;
- •FVC equal to or more than 70%;
- •patients who are either riluzole naive or patients who are receiving concomitant treatment with riluzole at a stable dose of riluzole (50 mg bid) at study start.
排除标准
- •Known or suspected chronic infectious disease including HIV, hepatitis B, or hepatitis C.
- •Clinically significant ECG abnormalities.
- •Known hypersensitivity to study drug or related drugs (e.g. selegiline, MAO-A and B inhibitors, or tricyclic antidepressants).
- •Patients treated with potent inhibitors of CYP1A2 or CYP3A4 (a list of such inhibitors will be provided to the investigator).
- •Treatment with MAO-A and B inhibitors (including selegiline) within the past 30 days.
结局指标
主要结局
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
次要结局
- Survival time
- Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit except screening)
- Neurocognitive evaluation in a subset of patients(every visit except screening)
研究者
研究点 (11)
Loading locations...
相似试验
已完成
2 期
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)Irritable Bowel Syndrome With ConstipationNCT00460811Ironwood Pharmaceuticals, Inc.420
已完成
2 期
Study To Assess FRacTure Healing With SclerosTin Antibody - HipFracture HealingNCT01081678Amgen332
已完成
1 期
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A SubjectsCongenital Bleeding DisorderHaemophilia ANCT02490787Novo Nordisk A/S24
已完成
4 期
A Phase 4 Study of Efficacy and Safety of Apremilast in Subjects With Moderate Plaque Psoriasis.ParapsoriasisNCT02425826Amgen221
终止
3 期
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial HypertensionPulmonary HypertensionNCT00302211Actelion67