EUCTR2014-004567-21-IE进行中（未招募）1 期
Effects of ODM-109 on respiratory function in patients with ALS. A randomised, double blind, placebo-controlled, cross-over, 3-period, multicentre study with open-label follow-up extension - LEVALS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •1. Written or verbal informed consent (IC) for participation in the study
- •will be obtained from the subject . In case the study subject him/herself
- •cannot sign the IC due to severe muscle weakness, a witness may sign
- •the consent form to indicate that the subject has given verbal consent.
- •2. Age of at least 18 years.
- •3. Male or female subjects with diagnosis of laboratory supported
- •probable, probable or definite ALS according to El Escorial revised
- •criteria (Brooks BR et al., 2000). Full electromyogram (EMG) report
- •available consistent with ALS (but not necessarily fulfilling
- •electrodiagnostic criteria for ALS) from an experienced
- •neurophysiologist.
- •4. Ability to swallow the study treatment capsules.
- •5. An upright (sitting position) Slow Vital Capacity between 60-90% of the predicted value for age, height and sex at screening visit.
- •6. Normal oxygen saturation during daytime (measure of = 95% when steady state has been reached with a reliable read) in sitting position measured by pulse oximetry.
- •7. Disease duration from symptom onset (defined by first muscle
- •weakness or dysarthria) of 12-48 months at the time of baseline/day 1
- •of the first treatment period.
- •8. Patients with or without riluzole. If using riluzole, the dose must have
- •been stable for at least 4 weeks prior to screening and should not be
- •changed during the cross-over, doubleblind part of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Subject in whom other causes of neuromuscular weakness have not been excluded.
- •2. Subject with a diagnosis of another neurodegenerative disease
- •3. Assisted ventilation or gastrostomy of any type during the preceding 3 months prior to screening or predicted to be required within the randomised, double-blind cross-over part of the study
- •4. Recorded diagnosis or evidence of major psychiatric diagnosis, significant cognitive impairment or clinically evident dementia
- •5. Haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy
- •6. Acute myocardial infarction or any other acute coronary event within 1 month before the screening visit
- •7. Any major surgery within 1 month before the screening visit or patients who are scheduled for any major surgery during the planned study period
- •8. History of Torsades de Pointes, family history of long QT-syndrome or history of life-threatening ventricular arrhythmia within 3 months before screening
- •9. Heart Rate of less that 50 or greater than 100 beats per minute as an average over the 24-hour ambulatory Holter-ECG recording at screening
- •10. Systolic blood pressure (SBP) less than 100 mmHg or greater than 180 mmHg, or diastolic blood pressure (DBP) greater than 100 mmHg at screening.
- •11. Ventricular tachycardia (wide complex tachycardia greater than 100/min, greater than 5 consecutive beats) in the 24-hour ambulatory Holter-ECG recording at screening.
- •12. Episode of atrial fibrillation or atrial flutter lasting greater than 60 seconds in 24-hour ambulatory Holter-ECG recording at screening.
- •13. Second or third degree atrioventricular (AV) block in the 12-lead ECG or in the 24-hour ambulatory Holter-ECG recording at screening.
- •14. Potassium less than 3.7 mmol/l or greater than 5.5 mmol/l at screening
- •15. Creatinine greater than 170 µmol/l at screening or on dialysis.
- •16. Blood haemoglobin less than 10 g/dl at screening.
- •17. Clinically significant hepatic impairment at the discretion of the investigator.
- •18. Women of reproductive age without a negative pregnancy test and without a commitment to using an acceptable method of barrier or hormonal contraception (e.g. condoms, diaphragms, oral contraceptives 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.
- •19. Known hypersensitivity to levosimendan.
- •20. Administration of levosimendan within 30 days prior to screening visit.
- •21. Any botulinum toxin use within 3 months from screening. Use of
- •botulinum toxin is not allowed during double-blind, cross-over part of
- •22. Patients with known history of human immunodeficiency virus (HIV) infection.
- •23. Any other clinically significant cardiovascular, pulmonary, 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.
- •24. Blood donation or loss of significant amount of blood within 60 days prior to screening.
- •25. Participation in a clinical trial with any experimental
研究者
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