CTIS2024-513960-24-00进行中（未招募）1 期
Effects of ozanimod on myelin dynamics and neurodegeneration in patients with relapsingremitting multiple sclerosis: correlation with disease activity, cognition, fatigue,depression and quality of life
Ospedale San Raffaele S.r.l.0 个研究点目标入组 30 人开始时间: 2024年5月29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
- 30
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（—）
- 性别
- All
入选标准
- •For RRMS patients: Age between 18 and 55 years (in line with phase III RCTs);, For RRMS patients:A diagnosis of RRMS according to the 2017 Revisions of the McDonald criteria;, For RRMS patients: RRMS patients starting treatment with ozanimod, according to European Medicines Agency (EMA) and Italian Medicine Agency (AIFA) criteria (if available at the moment of study initiation);, For RRMS patients: EDSS score =5.0 (in line with phase III RCTs);, For RRMS patients: Planned vaccinations completed prior to enrollment;, For RRMS patients: Provide informed consent signed for participation in the trial;, For RRMS patients: Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter.* * NOTE where the use of effective contraception is a protocol requirement a section on Contraception and Pregnancy should be added to the safety reporting section with corresponding information in the Participant Information Sheet., For HC subjects: Age between 18 and 55 years;, For HC subjects: Provide informed consent signed for participation in the trial.
排除标准
- •For RRMS patients: Age <18 or >55 years;, For HC subjects: Age <18 or >55 years;, For HC subjects: Major medical illnesses including neurological, cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;, For HC subjects: History of psychiatric or mood disorders, or of drug or alcohol abuse;, For HC subjects: MRI contraindications;, For HC subject: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial (positive urine ß-subunit of HCG)., For RRMS patients: Contraindications to ozanimod treatment as reported by EMA and AIFA (if available) recommendations;, For RRMS patients: Major medical illnesses including neurological (apart MS), cardiac, renal, hepatic, orthopedic, or rheumatologic disorders;, For RRMS patients: History of psychiatric or mood disorders, or of drug or alcohol abuse;, For RRMS patients: MRI contraindications, including claustrophobia, pregnancy, breastfeeding or metal implants;, For RRMS patients: One or more symptomatic treatment(s) (e.g., antidepressants, myorelaxants, psychoactive drugs) started/modified within the 3 months before ozanimod start;, For RRMS patients: The participant has previously participated in any clinical trial of ozanimod;, For RRMS patients: The participant is accommodated in an institution because of a regulatory or legal order, is a prisoner, or is legally institutionalized;, For RRMS patients: Female participant who is pregnant, lactating or planning pregnancy during the course of the trial. (positive urine ß-subunit of human chorionic gonadotropin [HCG]).
研究者
相似试验
招募中
4 期
Effect of ozanimod on meningeal inflammation and glial activation in Multiple Sclerosis: one year phase 4 experimental study2024-518859-27-00Azienda Ospedaliera Universitaria Integrata Verona50
尚未招募
3 期
The effect of midazolam drug on the occurrence of restlessness and agitation in patients undergoing electroshock therapyPatients undergoing electroshock therapy.IRCT20170108031818N3Gorgan University of Medical Sciences100
已完成
3 期
Oxymetazoline Drops for Acquired Blepharoptosis From SynkinesisBlepharoptosisSynkinesisHyperkinesisFacial ParalysisNCT05945615Milton S. Hershey Medical Center36
招募中
Unknown
The influence of remimazolam on the neuromuscular transmissioPatients scheduled for elective surgery under general anesthesia in the supine positionJPRN-jRCT1071230039Fujimoto Masafumi15
已完成
不适用
The investigation of changes in brain monoamine oxidase-B and their relation to pathologies in mild cognitive impairmentMild cognitive impairment, Healthy volunteerJPRN-UMIN000043458ational Institutes for Quantum and Radiological Science and Technology30