NL-OMON42324已完成不适用
An open label, cross over pilot study to evaluate the effect of a single dose of TW001 on the oxidative stress and pharmacokinetics with and without food in patients with amyotrophic lateral sclerosis - Pilot phase IB study with TW001
Treeway B.V.0 个研究点目标入组 8 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of written informed consent and compliance with study procedures
- •2. Diagnoses of definite, probable or possible ALS according to the El Escorial criteria, supported by laboratory values and confirmed by a trained and qualified expert physician
- •3. Aged between 18 and 70 years of age (both inclusive)
- •4. Women must not be able to become pregnant (post-menopausal for at least a year, surgically sterile or practicing adequate birth control methods) for the duration of the study
- •5. Women of childbearing potential must have a negative serum pregnancy test at screening and be non-lactating
- •6. Vital capacity equal to or more than 70% predicted normal value for gender, height and age at screening
- •7. No clinically significant abnormality on 12-lead ECG performed at screening
排除标准
- •1. Other causes of neuromuscular weakness have not been excluded
- •2. Significant cognitive impairment, clinical dementia or psychiatric illness
- •3. Diagnosis of other neurodegenerative disease
- •4. Significant pulmonary disorder not attributed to ALS, requirement of treatment complicating evaluation of ALS on respiratory function
- •5. History of known sensitivity or intolerability of edaravone or to any related compound
- •6. Severe disturbance of consciousness
- •7. Hepatic impairment as indicated by Child-Pugh Class B or C (moderate to severe hepatic insufficiency)
- •8. Renal impairment as indicated by a creatinine clearance of less than 50 mL/min as calculated by the Cockcroft Gault equation using serum creatinine.
- •9. Serious difficulty swallowing and/or inability to eat high-fat high-calorie meal
- •10. Tracheostomy or non-invasive ventilation
- •11. Administration of antibiotics, CYP3A4 and or PgP inhibitors
- •12. Smoking
- •13. Advanced cancer
- •14. Exposure to any investigational drug within 30 days of the screening visit
- •15. Malnourishment based on laboratory data, dehydration or on a sodium free diet
- •16. Presence of any of the following clinical conditions:
- •a. Substance abuse within the past year
- •b. Uncontrolled cardiac, pulmonary, renal, hepatic, endocrine, hematologic or active infectious disease
- •c. AIDS or AIDS related disease, hepatitis B virus (HBV) or hepatitis C virus (HCV)
- •d. Unstable psychiatric illness defined as psychosis, untreated major depression within 90 days of the screening visit
研究者
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