NCT05923905招募中4 期
Randomized Double-blind Controlled Exploratory Clinical Study to Evaluate the Efficacy and Safety of FB1006 in the Treatment of ALS Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score
研究概览
简要总结
This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients.
详细描述
This is a randomized double-blind controlled exploratory clinical study to evaluate the efficacy and safety of FB1006 in the treatment of amyotrophic lateral sclerosis (ALS) patients. The study has two phases: the first phase is 24 weeks, using a randomized double-blind placebo-controlled design; the second phase is 24 weeks, using an open-label study design. FB1006 was approved by the National Medical Products Administration（NMPA）on June 21, 2021.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •World Federation of Neurology modified El Ecorial criteria for diagnosis of patients with laboratory support probable, clinically probable, or definite sporadic and familial amyotrophic lateral sclerosis (ALS)
- •Age 18 to 80 years old
- •ALS duration no longer than 18 months(from day of onset)
- •Patient 's ALSFRS-R total scored ≥27，Each single item is scored at least 2（dyspnoea, orthopnea and respiratory insufficiency ≥3）
- •Forced vital capacity (FVC%) no less than 70% of predicted normal for gender, height and age
- •According to brain function AI analysis in accordance with depressive EEG characteristics
- •Women and men of childbearing potential should use medically acceptable contraception
- •Voluntarily participate, and sign an informed consent form
排除标准
- •Patients with dementia or severe neurological, psychiatric or systemic disease that is poorly controlled or may interfere with the conduct of the trial or the results of the trial
- •Pregnant women and lactating women
- •Suicide attempt or attempted suicide
- •Combined with other neurological diseases similar to ALS symptoms, or affecting the evaluation of drug efficacy, such as cervical spondylotic myelopathy, lumbar spondylosis, dementia, etc.
- •Patients with history of spinal surgery after ALS onset
- •ALT or AST > 2 times ULN，creatinine clearance < 60 mL/min/1.73m2 (MDRD)
- •Patients who are allergic to the investigational product
- •Having participated in other clinical studies within 3 months before randomization
- •Patients that the investigator considers unsuitable for participation in the study
研究组 & 干预措施
placebo group
Placebo Comparator
Take placebo at night,30mg/day
干预措施: Placebo (Drug)
FB1006 test group
Experimental
Take FB1006 at night,30mg/day
干预措施: FB1006 (Drug)
结局指标
主要结局
ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score
时间窗: 24 weeks
Changes in ROADS from baseline to 24 weeks. ROADS score ranges from 0 to 56 points, and higher scores indicate better basic daily function.
次要结局
- MUNIX (Motor Unit Number Index)(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
- Body Weight(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
- ALSFRS-R (Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised) Score(24 weeks)
- FVC% (Forced Vital Capacity)(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
- Metabolic Level(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
- MRC (Medical Research Council) Scale(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
- Hand Delicate Function(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
- ALSFRS-R Score(12 weeks, 36 weeks, and 48 weeks)
- Language Disorders(12 weeks, 24 weeks, 36 weeks, and 48 weeks.)
- ROADS (Rasch-Built Overall Amyotrophic Lateral Sclerosis Disability Scale) Score(4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks)
- ALSAQ-40 (Amyotrophic Lateral Sclerosis Assessment Questionnaire-40) Score(12 weeks, 24 weeks, 36 weeks, and 48 weeks)
- Zung 's Self-Rating Depression Scale(4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, and 48 weeks.)
研究者
研究点 (1)
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