NL-OMON44970已完成3 期
A prospective, multicenter, randomised, double-blind, placebo-controlled, parallel groups, phase 2/3 study to compare the efficacy and safety of masitinib versus placebo in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS) - AB10015
AB Science0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
Trial is onging in other countries
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. Female or male patient aged between 18 and 75 years of age, with a
- •weight > 50 kg and BMI between 18 and 35 kg/m².
- •2. Familial or sporadic ALS
- •3. Patient diagnosed with laboratory supported, clinically probable or
- •definite ALS according to the World Federation of Neurology Revised El
- •Escorial criteria (Brooks, 1994)
- •4. Disease duration from symptoms onset no longer than 36 months at
- •the screening visit
- •5. Patient treated with a stable dose of riluzole (100 mg/day) for at
- •least 30 days prior to screening
- •6. Patient with a FVC (Forced Vital Capacity) equal to or more than 60%
- •predicted normal value for gender, height, and age at the screening visit
- •7. Patient with life expectancy >= 6 months
- •8. Patient with adequate organ function at screening and baseline:
- •Absolute Neutrophils Count (ANC) >= 2 x 109/L
- •Hemoglobin >= 10 g/dL
- •Platelets (PTL) >= 100 x 109/L
- •AST/ALT <= 3 ULN
- •Bilirubin <= 1.5 ULN
- •Albuminemia > 1 x LLN
- •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
- •9. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. Acceptable forms of contraception are explained in the protocol (v4.0 dd16-Mar-2015) on page 5.
- •10. Male patients must use medically acceptable methods of contraception if your female partner is pregnant, from the time of the first administration of the study drug until three months following administration of the last dose of study drug. Acceptable methods are explained in the protocol on page 5.
- •Male patients must use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. Acceptable methods are explained in the protocol on page 5.
- •11. Female patient of childbearing potential must have a negative
- •pregnancy test at screening and baseline
- •12. Patient able and willing to comply with study procedures as per
- •13. Patient able to understand, and willing to sign, and date the written
- •informed consent form at screening visit prior to any protocol-specific
- •14. 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, during the first two
- •months of treatment
排除标准
- •1. Patient with history of hematologic, hepatic, respiratory disorder
- •that is clinically significant for his/her participation in the study
- •2. Patient who underwent tracheotomy and /or gastrostomy
- •3. Patient with a diagnosis of cancer or evidence of continued disease
- •within five years before starting study treatment
- •4. Patient with significant sensory abnormalities, dementia, other
- •neurologic diseases, uncompensated medical illness and psychiatric
- •5. Patient who have participated in a clinical trial within 3 months prior
- •to screening
- •6. Pregnant, or nursing female patient
- •7. Patient with a known diagnosis of human immunodeficiency virus
- •(HIV) infection
- •8. Patient with known hepatitis B, hepatitis C or tuberculosis
- •9. Patient with any severe and/or uncontrolled medical condition
- •10. Patient having cardiac disorders defined by at least one of the
- •following conditions:
- •Patient with recent cardiac history (within 6 months) of:
- •- Acute coronary syndrome
- •- Acute heart failure (class III or IV of the NYHA classification)
- •- Significant ventricular arrhythmia (persistent ventricular tachycardia,
- •ventricular fibrillation, resuscitated sudden death)
- •Patient with cardiac failure class III or IV of the NYHA classification
- •Patient with severe conduction disorders which are not prevented by
- •permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •Syncope without known aetiology within 3 months
- •Uncontrolled severe hypertension, according to the judgment of the
- •investigator, or symptomatic hypertension
- •11. Patient with history of poor compliance or history of drug/alcohol
- •abuse, or excessive alcohol beverage consumption that would interfere
- •with the ability to comply with the study protocol, or current or past
- •psychiatric disease that might interfere with the ability to comply with
- •the study protocol or give informed consent;12. Patient treated with any investigational agent within 3 months prior
- •to screening
研究者
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