EUCTR2019-001862-13-IT进行中（未招募）1 期
A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with Riluzole versus placebo in combination with Riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - non applicable
AB SCIENCE0 个研究点目标入组 495 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 495
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. Patient, male or female, diagnosed with laboratory supported probable, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria
- •2. Patient with a familial or sporadic ALS
- •3. Patient aged between 18 and 75 years old inclusive at screening
- •4. Patient treated with a stable dose of Riluzole (100 mg/day) for at least 12 weeks prior to the baseline visit
- •5. Patient with an ALS disease duration from diagnosis no longer than 24 months at screening
- •6. Patient with an ALSFRS-R total score progression between onset of the disease and screening of > 0.3 and <1.1 point/month
- •7. Patient with an ALSFRS-R total score decrease equal or greater than 1 point between screening and baseline
- •8. Patient with an ALSFRS-R total score of at least 26 at screening following rules below:
- •- at least 3 on item #3 and
- •- at least 2 on each of the other 11 items (i.e. item #1, #2, #4, #5a or #5b, #6, #7, #8, #9, #10, #11 and #12)
- •9. Patient with an ALSFRS-R total score of at least 25 at randomization following rules below:
- •- at least 3 on item #3 and
- •- at least 2 on each of the other 11 items (i.e. item #1, #2, #4, #5a or #5b, #6, #7, #8, #9, #10, #11 and #12)
- •10. Contraception:
- •- Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an effective method of contraception by her male partner during the study and for 3 months and a half after the last treatment intake
- •- Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an effective method of contraception by his female partner during the study and for 3 months and a half after the last treatment intake OR who agrees to use an effective method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months and a half after the last treatment intake
- •Highly effective and effective methods of contraception are detailed in appendix 15.1 of the protocol
- •11. Patient able to understand, and willing to sign, and date the written informed consent form prior to any protocol-specific procedures. If patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation
- •12. Patient able and willing to comply with study protocol and to come on-site as per protocol visits schedule
- •13. Patient able to understand, and willing to follow the safety procedures mentioned on the patient card in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1. Patient with dementia or significant neurological, psychiatric, systemic or organic disease, uncontrolled or that may interfere with the conduct of the trial or its results
- •2. Patient with hypersensitivity to masitinib excipients
- •3. Patient with an FVC < 60% predicted normal value for gender, height, and age at screening
- •4. Patient with a weight < 41 kg and a BMI < 21 or > 30 kg/m² at screening and at baseline
- •5. Pregnant, or nursing female patient
- •6. Patient with history (or family history) of severe skin toxicities or reactions
- •7. Patients treated by drugs known to be at high risk for Stevens-Johnson Syndrome or for Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome
- •8. Patient with history of severe bone marrow disorders such as agranulocytosis or aplasia, or with abnormal laboratory results from local laboratory assessments at screening and baseline :
- •- Neutropenia with ANC < 1.5x109/L
- •- Anemia with Hgb < LLN and red blood cell count below the LLN
- •- Thrombocytopenia with platelets counts < 150 x 109/L
- •9. Patient with history of hepatic disorders, with a known liver disease or recent alcohol abuse, or with abnormal laboratory results from local laboratory assessments defined as:
- •- Hepatic transaminase levels > 2 ULN at baseline, or
- •- Total bilirubin level > 1.5 ULN at baseline, or
- •- Both hepatic transaminase levels and total bilirubin level outside of the normal ranges at screening and baseline, or
- •- Albuminemia < 1 x LLN at screening and baseline
- •10. Patient with pre-existing severe renal impairment, or with abnormal laboratory results from local laboratory assessments at screening and baseline :
- •- Creatinine clearance < 60 mL/min (Cockcroft and Gault formula)
- •- Proteinuria > 30 mg/dL (1+) on dipstick; in case of the proteinuria equal or greater than 1+ on the dipstick, 24 hours proteinuria must be > 1.5g/24 hours
- •11. Patient with active severe infection such as herpes, tuberculosis, viral hepatitis, human immunodeficiency virus infection
- •12. Patient with autoimmune conditions such as systemic lupus erythematosus
- •13. Patient with a diagnosis of cancer or evidence of continued disease within five years before screening
- •14. Patient with severe cardiac conditions:
- •- Patient with recent history of severe cardiovascular conditions including acute myocardial infarction, unstable angina pectoris, coronary revascularization procedure, congestive heart failure of NYHA Class III or IV, stroke, including a transient ischemic attack
- •- Patient with cardiac conduction abnormalities at study entry including a QTc Fredericia interval >450 milliseconds for males and >470 milliseconds for females, a second- or third-degree atrioventricular block not successfully treated with a pacemaker
- •- Patient presenting with edema of cardiac origin and left ventricular ejection fraction = 50%
- •15. Patient with risk factors for sudden unexpected death of cardiovascular origin
- •16. Patient who has been exposed to an investigational treatment within 3 months prior to screening
- •17. Patient who has been exposed to Edaravone within at least 30 days prior to screening
- •18. Patient treated concomitantly with drugs known to interact with cytochrome P450 (CYP450) isoenzymes (2C9, 2D6 and 3A4)
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