EUCTR2018-004180-31-FR进行中（未招募）1 期
Effects of oral Levosimendan (ODM-109) on respiratory function in patients with ALS: open label extension for patients completing study 3119002 - REFALS-ES
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following criteria to be included into the study:
- •1.Written or verbal informed consent (IC) for participation in the study will be obtained from the subject. In case that the study subject him/herself cannot sign the IC, a witness may sign the consent form to indicate that the subject has given verbal consent.
- •2. Subjects who completed 48 weeks of treatment according to the REFALS study protocol.
- •3. Able to swallow study treatment capsules at the time of completing 48 weeks dosing in the REFALS study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 440
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Subjects will not be included into this study if they meet any of the following criteria:
- •1. Development (or significant worsening from baseline of the REFALS study) of serious cardiovascular disease (e.g. myocardial infarction, heart failure, arrhythmia, stroke, or second or third degree atrioventricular (AV) block).
- •2. Pulse/heart rate repeatedly > 100 bpm after 5-minute rest at baseline. If the pulse/heart rate is > 100 bpm in the first recording, then a second recording must be done after another 5 min rest to confirm pulse/heart rate > 100 bpm.
- •3. Systolic blood pressure (SBP) < 90 mmHg.
- •4. Severe renal impairment (creatinine clearance < 30 ml/min or creatinine > 170 µmol/l at 48 week visit of the REFALS study, or on dialysis.
- •5. Severe hepatic impairment at the discretion of the investigator.
- •6. Women of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g. oral hormonal contraceptives associated with inhibition of ovulation, intrauterine devices and long acting progestin agents), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included.
- •7. Subject judged to be actively suicidal by the investigator.
- •8. Any other clinically significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study.
研究者
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