EUCTR2008-007320-25-BE进行中（未招募）1 期
Phase II/III, multicenter, randomized, parallel group,double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- TROPHOS SA
- 入组人数
- 470
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. Patients with sporadic or familial Amyotrophic Lateral Sclerosis
- •2. Patients with a clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to the modified El Escorial criteria .
- •3. Have signed an Informed Consent to participate to the trial before any study related procedure has taken place.
- •4. Be of age >18 and < 80 years.
- •5. If a female, not lactating, has a negative pregnancy test and agrees to use an effective method of birth control.
- •6. Onset of ALS Symptoms (weakness) for more than 6 months and less than 36 months.
- •7. Slow vital capacity (SVC), concordant after 3 measures, =70% of that predicted.
- •8. Treated with riluzole at the stable dose of 50 mg bid for at least 30 days before enrolment
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Tracheostomy, invasive ventilation, or non invasive positive pressure ventilation (NIPPV).
- •2. Gastrostomy.
- •3. Evidence of major psychiatric disorder or clinically evident dementia.
- •4. Diagnosis of a neurodegenerative disease in addition to ALS.
- •5. Have a current medication that could interfere with TRO19622 pharmacokinetics: tamoxifene
- •6. Have current medications that could interfere with TRO19622 absorption such as ezetimibe,bile salts chelators, fibrates, phytosterols, fish oils. Have a current medication of lipid lowering agents other than statins.
- •7. Known hypersensitivity to any component of the study drug.
- •8. Patients with known intolerance or contra-indication to riluzole.
- •9. Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
- •10. Have concurrent unstable disease involving any system eg, carcinoma other than basal cell carcinoma, any cardiac dysrhythmia, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency, angina symptoms, current symptoms of Coronary Artery Disease, or any other condition that in the opinion of the Investigator would make the patient unsuitable for study participation.
- •11. Having a baseline QTc (Bazett) > 450 msec.
- •12. Patients with known hepatitis B/C or HIV positive serology.
- •13. Be pregnant female or lactating.
- •14. Have renal impairment defined as blood creatinine > 1,5 x upper limit of normal.
- •15. Have hepatic impairment and/or liver enzymes (ALT or AST) > 3x ULN.
- •16. Hemostasis disorders or current treatment with oral anticoagulants.
- •17. Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated employee).
- •18. Participated in any other investigational drug or therapy study with a non approved medication, within the previous 3 months.
- •19. Patients without Social Security Insurance (France).
研究者
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