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临床试验/EUCTR2019-001862-13-NO
EUCTR2019-001862-13-NO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

ABScience0 个研究点目标入组 495 人开始时间: 2020年11月20日最近更新:
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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
研究概览入排标准研究者记录与标识符相似试验

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 [52]
  • •2.Patient with a familial or sporadic ALS
  • •3.Patient aged between 18 and 80 years old inclusive at screening
  • •4.Patient treated with a stable dose of Riluzole (100 mg/day) for at least 12 weeks prior to 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 of = 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
  • •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 or its excipients, placebo or its excipients and riluzole or its 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 > 35 kg/m² at screening 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 screening and baseline :
  • •-Neutropenia with ANC < 1.5x109/L
  • •-Anemia with Hgb < LLN or 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) 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 five years before screening
  • •14.patients with (an history of) severe cardiovascular disease:
  • •-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.
  • •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) x T (number years smoking)) Patients who stopped smoking 6 months prior to the evaluation, are not concerned.
  • •-Hypercholesterolemia
  • •This assessment is done according to the Systematic Co

研究者

发起方
ABScience

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