EUCTR2010-021219-17-DE进行中（未招募）1 期
A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis - Not applicable
AB Science0 个研究点目标入组 600 人开始时间: 2011年7月5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
- 600
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
入选标准
- •1. Patient suffering from either primary progressive or secondary progressive multiple sclerosis without relapse within 2 years before inclusion according to the revised McDonald’s criteria
- •2. Patient with EDSS score of [2.0 to 6.0] inclusive at baseline
- •3. Patient who had an EDSS score progression = 1 point within 2 years before inclusion
- •4. Patient with normal organ function defined as:
- •Absolute neutrophils count (ANC) = 2 x 109/L
- •Hemoglobin = 10 g/dL
- •Platelets (PTL) = 100 x 109/L
- •AST/ALT = 3 ULN
- •Bilirubin = 1.5x ULN
- •Creatinine clearance > 60 mL/min (Cockcroft and Gault formula)
- •Albuminemia > 1 x LLN
- •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
- •5. Male or female patient aged between 18 and 75 years old, with a weight > 50 kg and BMI between 18 and 35 kg/m².
- •6. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment.
- •7. 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 include:
- •8. 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 include:
- •9. Patient able and willing to comply with study procedures as per protocol
- •10. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Patient suffering from a disease other than MS that would better explain the patient’s neurological clinical signs and symptoms and/or MRI lesions
- •2. Patient who had a major surgery within 2 weeks of study entry
- •3. Patient with life expectancy < 6 months
- •4. Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ
- •5. Patient presenting with 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
- •6. Patient with any severe and/or uncontrolled medical condition
- •7. Patient with a known diagnosis of human immunodeficiency virus (HIV) infection
- •8. Patient with known hepatitis B, hepatitis C or tuberculosis
- •9. Pregnant or nursing female
- •10. 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
- •11. Patient with any condition or concurrent medical events, including any clinically significant deviations from reference ranges in laboratory test, that on the opinion of the physician could be detrimental to the subjects
- •12. Patients requiring medication, which are prohibited in the current protocol, including corticosteroids used other than defined by the protocol, chemotherapies, immunomodulators or immunosuppressors, investigational drugs, live attenuated vaccines, drugs known to be at high risk of Stevens-Johnson syndrome.
研究者
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