EUCTR2019-001862-13-PL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) - not applicable
AB Science0 个研究点目标入组 495 人开始时间: 2020年7月9日最近更新:
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 80 years old inclusive at the time of signing the informed consent
- •4. Patient treated with a stable dose of Riluzole (100 mg/day) for at least 30 days prior to screening visit
- •5. Patient with an ALS disease duration from diagnosis no longer than 24 months at screening
- •6. Patient with onset of first symptom of ALS no longer than 36 months at screening
- •7. Patient with a ALSFRS-R progression rate of > 0.3 and <1.1 point/month
- •i) as measured between onset of the disease and screening AND
- •ii) as measured by any available ALSFRS-R assessment during the period ranging from 7 months to 2 months prior to screening and screening, reassessed and documented by the same certified rater performing ALSFRS-R assessment from screening visit onward
- •8. Patient with an ALSFRS-R total score at screening and baseline following rules below:
- •- at least 3 on item #3 and
- •- at least 2 on item #12 and
- •- at least 1 on each of the other 10 items (i.e. item #1, #2, #4, #5a or #5b, #6, #7, #8, #9, #10, and #11)
- •9. Contraception:
- •- Female patient of childbearing potential (entering the trial 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 trial and for 8 months 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 trial and for 5 months 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 trial and for 5 months after the last treatment intake
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. Highly effective and effective methods of contraception are detailed in appendix 15.1
- •10. 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 trial 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 trial participation.
- •11. Patient able and willing to comply with trial protocol and to come on-site as per protocol visits schedule
- •12. 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 or its excipients, placebo or its excipients and riluzole or its excipients
- •3. Patient with an FVC < 70% predicted normal value for gender, height, and age at SCR and baseline
- •4. Patient with a weight<41kg and a BMI<18 or >35 kg/m² at SCR or 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 SCR and baseline :
- •- Neutropenia with ANC<1.5x109/L
- •- Anemia with Hgb- 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 SCR and baseline
- •- Patients with concomitant medication known to be associated with severe hepatotoxicity
- •10. Patient with pre-existing severe renal impairment, or with abnormal laboratory results from local laboratory assessments at SCR and baseline :
- •- Creatinine clearance <60 mL/min (Cockcroft and Gault formula) or
- •- Proteinuria >30 mg/dL (1+) on dipstick; in case of the proteinuria = 1+ on the dipstick, 24 hours proteinuria must be > 1.5g/24 hours
- •11. Patient with active severe infection such as 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 5 years before SCR
- •14. Patients with current or history of severe cardiovascular disease, assessed at SCR
- •- Myocardial infarction,
- •- Unstable angina pectoris
- •Coronary revascularization procedure
- •- Congestive heart failure of NYHA Class III or IV
- •- Stroke, including a transient ischemic attack,
- •- Second degree or third-degree atrioventricular block not successfully treated with a pacemaker,
- •- Bi-fascicular block,
- •- QTc Fridericia interval >450 milliseconds for males and >470 milliseconds for females,
- •- Drug induced heart failure or ischemic heart disease.
- •- Radiotherapy induced cardiomyopathy.
- •- Family history of unexpected death of cardiovascular origin.
- •- oedema of cardiac origin and left ventricular ejection fraction = 50%
- •15. Patients, with two or more of the risk factors listed below assessed by a cardiologist as Very High Risk (calculated SCORE =10%.) or High Risk calculated SCORE =5% and <10%) according to the Systematic Coronary Risk Estimation (SCORE):
- •- Hypertension (uncontrolled)
- •- Kidney disease,
- •- Current tabagism (=10 Pack-year: equivalent to 1 pack of 20 cigarettes for 10 years with the formula N (number of packs of 20 cigarettes smoked daily) xT (number years smoking)) Patients who stopped smoking 6 months p
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