NL-OMON41963撤回3 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 - AB07002
AB Science0 个研究点目标入组 13 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 13
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 64（—）
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.Man and woman of childbearing potential (entering the study after a menstrual period, and who have a negative pregnancy test) must agree to use two 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.
- •8. Patient able and willing to comply with study procedures as per protocol
- •9. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
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
- •Major surgery includes all work requiring a general anesthetic. Thus all operations which involve openings into the great cavities of the body; all operations in the course of which hazards of severe hemorrhage are possible; all conditions in which the life of the patient is at stake; all conditions which require for their relief manipulations or for the proper performance of which special anatomical knowledge and manipulative skill are essential.
- •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
- •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 active hepatitis B, hepatitis C or tuberculosis
- •9. Pregnant or nursing female
研究者
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