NCT05240560终止2 期
A Multisite Randomized Clinical Trial Evaluating Efficacy and Safety of BP1.3656 vs Placebo in Patients With Fatigue Following Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bioprojet
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Multidimensional Fatigue Inventory (MFI-20) global score
研究概览
简要总结
Multicenter, randomized, double blind, parallel-group, placebo-controlled proof of concept study evaluating efficacy and safety of BP1.3656 in patients with fatigue following ischemic stroke.
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)
盲法说明
The placebo tablets will be identical in appearance to the BP1.3656 tablets.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 18 years old or more;
- •Diagnosis of ischemic stroke at least one month and not more than six months prior to screening;
- •Persistent fatigue since the stroke with a score ≥ 50 across all domains of the Multidimensional Fatigue Inventory (MFI-20);
- •Modified Rankin Score (mRS) < 3;
- •Capability to participate in all study tests according to the investigator;
- •Patient must voluntarily express a willingness to participate in this study, sign and date an informed consent prior to any study specific procedure;
- •Females of child-bearing potential must have a negative pregnancy test performed at the screening and randomization visits and use a medically accepted effective method of birth control, agree to continue this method for the duration of the study up until three weeks after last treatment intake.
排除标准
- •Any identified etiology for fatigue other than stroke (except post-stroke depression) according to the investigator;
- •History of psychosis;
- •Current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression, or organic brain syndrome preventing the patients from completing study assessments;
- •Patients at risk of suicide according to the investigator;
- •Major cognitive disorders, dementia according to the investigator;
- •History of epilepsy or seizures disorder;
- •History of alcohol or drugs (i.e. cannabis, cocaine, amphetamines or opioids) (ab)use/dependence within the 12 months prior to screening or with a positive drug test at screening;
- •Glomerular filtration rate <60 mL/min/1.73m² according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula;
- •Clinically significant cardiovascular abnormalities (including clinically relevant ECG abnormalities) or, clinically significant hematological, neurological, endocrine abnormalities, severe hepatic impairment or Liver Function Tests (ASAT, ALAT) > 3 ULN, or abnormal clinical laboratory results (in most cases > 3ULN);
- •Other active clinically significant illness, infection, acid-related gastric disorder, or neoplastic pathology within the last 3 years (patients with fully cured non-melanoma skin cancer or in-situ carcinoma of the cervix are eligible) which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise his/her study participation.
研究组 & 干预措施
BP1.3656
Experimental
1 tablet of 30 microgram (µg), 60µg or 90µg of BP1.3656 per day
干预措施: BP1.3656 (Drug)
Placebo
Placebo Comparator
1 tablet of matching placebo per day
干预措施: BP1.3656 (Drug)
结局指标
主要结局
Multidimensional Fatigue Inventory (MFI-20) global score
时间窗: Week 8
20-item self-report instrument designed to measure fatigue experienced by the participant lately scored from 20 to 100. Higher scores show higher levels of fatigue.
次要结局
未报告次要终点
研究者
研究点 (2)
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