EUCTR2020-005947-22-IT进行中（未招募）1 期
Effect of siponimod on relevant imaging and immunological hallmarks of progressive multiple sclerosis - Effect of siponimod on progressive multiple sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Age 18-65 years.
- •Active progressive MS course after an initial relapse clinical course defined as an EDSS progression of at least 1 point with a history of relapse and/or evidence of radiological activity defined as new/enlarging T2-FLAIR hyperintense or Gd-enhancing lesion on MRI acquired, in the previous 2 years before the enrolment.
- •Availability of a 3T MRI performed within the last 2 years. This MRI must include these sequences:
- •-3D T1 weighted Fast Field Echo (FFE)
- •-3D Fluid Attenuated Inversion Recovery (FLAIR)
- •-3D Echo Planar Imaging Susceptibility weighted (Magnitude and Phase)
- •Availability of a detailed clinical data on medical history with neurological evaluation performed at least twice in the past two years (or once in the past year).
- •EDSS between 3.0 and 6.0
- •Less than 5 years since entering the progressive phase of the disease.
- •Female subjects must not be pregnant or breast feeding at T0 nor during the study phase.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Medical conditions:
- •Patients homozygous for the CYP2C9 *3 *3 allele.
- •Immunodeficiency syndrome.
- •History of progressive multifocal leukoencephalopathy or cryptococcal meningitis.
- •Hematologic alterations (lymphocyte count not within normal limits)
- •Rheumatic disease under specific treatment (including chronic use of steroid)
- •Severe active infections (regard to positive result to HBV, HCV, HIV, Quantiferon)
- •Active malignities
- •Myocardial infarction, unstable angina, stroke (any time), TIA (in the last 6 months)
- •NYHA Class III or IV heart failure
- •Complete left bundle branch block
- •First- or second-degree [Mobitz type I] AV block,
- •Second grade AV block (Mobitz type II);
- •Third grade AV block (unless patient has a functioning pacemaker)
- •Sinus bradycardia (HR < 55 bpm) or symptomatic bradycardia (i.e. history of recurrent syncope)
- •QTc =500 msec
- •Severe liver dysfunction (i.e. transaminase and/or bilirubin levels > 3x ULN)
- •Negativity for varicella zoster IgG antibodies (in case of vaccination by live vaccine the beginning of therapy must be postponed of at least 30 days).
- •History of hypersensitivity to any metabolites or drugs of the same class as siponimod.
- •Hypersensitivity to the active substance or to peanuts, soy or to any of the excipients
- •Pregnancy or breast feeding.
- •Fertile women who do not use effective methods of contraception.
- •Previous and ongoing therapies:
- •¿Natalizumab (last dose less than 6 months prior to enrollment);
- •¿Rituximab, Ocrelizumab, Cyclophosphamide (last dose less than 1-year prior enrollment);
- •¿Fingolimod, Mitoxantrone therapy or evidence of cardiotoxicity or a cumulative dose greater than 60 mg/m2 (last dose less than 2-year prior enrollment)
- •¿Alemtuzumab, cladribine, autologous stem cell transplantation and other immunosuppressive treatments with expected effect of over 6 months (any time)
- •¿Intravenous corticosteroid cycle to treat MS clinical relapse (1-month before enrollment)
- •¿Antiarrhythmics Class Ia (e.g. quinidine, procainamide), Class III (amiodarone, sotalolo) drugs and those that may decrease heart rate (e.g. beta-blockers, calcium channel blockers, ivabradine and digoxin)
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