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) - AB19001

AB Science0 个研究点目标入组 11 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

阶段: 3 期
状态: 撤回
发起方
入组人数: 11

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

入排标准

年龄范围: 18 至 99（—）

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 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
•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 verbal
•consent is given, a Legal Representative of the patient must sign the informed
•consent form
•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

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
•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)
•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 * 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
•16. Patient who has been exposed to an investigational treatment within 3
•months prior to screening
另有 3 项未显示

研究者

发起方

AB Science

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