NCT00214110已完成2 期
Phase 2 Randomized Single-blind Escalating Dose Response Clinical Trial of Tamoxifen Therapy on Mean Percent Predicted Isometric Strength in Amyotrophic Lateral Sclerosis [ALS]
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
研究概览
简要总结
This is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (ALS). The purpose is to determine whether the triphenylethylenetamoxifen, used as adjuvant therapy in the treatment of breast cancer, can delay the loss of isometric muscle strength in ALS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically probable-laboratory supported, clinically probable, or clinically definite amyotrophic lateral sclerosis
排除标准
- •Allergic or idiosyncratic response to tamoxifen.
- •Other active neurologic diseases that may produce weakness, sensory loss, or autonomic symptoms.
- •Psychiatric, psychological, or behavioral symptoms that would interfere with the subject's ability to participate in the trial.
- •Clinically significant cardiac, pulmonary, gastrointestinal, hematologic, or endocrine (poorly controlled insulin-dependent diabetes mellitus or hyperthyroidism) disease that may confound interpretation of the study results.
- •Previous kidney or pancreas transplants.
- •Significant hepatic or renal disease (AST > 5 times normal, serum creatinine > 2.0 mg/dL for males or > 1.8 mg/dL for females).
结局指标
主要结局
Stability at 6, 12, 18 and 24 months on of the patient's mean percent predicted arm strength
次要结局
- Vital capacity, raw liters and percent predicted, compared with baseline measured at 3 month intervals.
- Individual arm and leg muscle mean percent predicted isometric strength compared with baseline measured at 3 month intervals.
- Bulbar, Breathing, arm and leg subscores of ALS Functional Rating Scale - Revised [ALS-FRS-R] compared with baseline measured at 3 month intervals.
- Total ALS Functional Rating Scale [ALS-FRS-R] compared with baseline measured at 3 month intervals.
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN)AMNAMN Gene MutationX-ALDNCT05394064SwanBio Therapeutics, Inc.9
已完成
1 期
An Evaluation of 9MW1911 Injection in Healthy SubjectsCOPDAtopic DermatitisAsthmaNCT05803902Mabwell (Shanghai) Bioscience Co., Ltd.48
已完成
1 期
Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 IllnessCOVID-19NCT05298813Immune Biosolutions Inc162
已完成
1 期
A Safety and Tolerability Study of CTP-730 in Healthy VolunteersHealthyNCT02239081Concert Pharmaceuticals55
已完成
1 期
Phase Ia Clinical Study of HDM1005 InjectionObesity and OverweightNCT06640647Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.65