NCT04211740已完成2 期
Efficacy and Safety of OCH-NCNP1 in Patients With Relapsing Multiple Sclerosis
National Center of Neurology and Psychiatry, Japan1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年12月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline
研究概览
简要总结
This study is designed to assess the efficacy and safety of OCH-NCNP1 compared to placebo in subjects diagnosed with relapsing remitting multiple sclerosis (RRMS) and secondary progressive mltiple sclerosis (SPMS) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject with Multiple Sclerosis eligible for enrolment in the study must meet all of the following criteria:
- •Provision of written informed consent to participate in this study
- •Patients diagnosed as relapsing remitting multiple sclerosis based on modified McDonald criteria in 2017
- •Relape must have been confirmed by a neurologist at least twice within 24 months, or once within 12 months before enrollment
- •Have at least one T2 lesion on MRI scans at screening
- •EDSS less than or equal to 7
- •20 =< Age < 65
- •Promise to prevent conception for at least 90 days after the last administration
- •Neurological stability has been confirmed by a neurologist
排除标准
- •Subject with MS patients meeting any of the following criteria must not be enrolled in the study:
- •Diagnosed as Neuromyelitis Optica
- •Women who are pregnant or lactating
- •Patients who is prohibited MRI
- •Patients who are allergic to Gd-contrast medium
- •History of liver diseases or liver transplantation
- •Liver dysfunction in the screening test and baseline physical examination
- •History of cancer past five years
- •Negative for herpes zoster virus antibody
- •Positive for Syphilis serum reaction
- •Positive for Beta-glucan or positive for T-spot
- •Positive for Anti-Aquaporin 4 antibody
- •History of HIV infection
- •History of HBV or HCV infection
- •History of Transplantation
- •Use of any other investigational agents and/or experimental agents within 4 months prior to the first anticipated administration of study medication.
- •History of blood donation (200 ml within 2 months, 400 ml within 3 months) prior to the first anticipated administration of study medication
- •Lymphocyte number < 600 /mm3 in peripheral blood
- •Current diagnosed or suspected infectious diseases
- •Compromised Patients
- •Inflammatory Bowel disease
- •Subjects with prolongation of QT/QTc interval
- •History or have risk of torsade de pointes
- •Taking the medicine which has risk of prolongation of QT/QTc interval
- •History of severe allergy of medicine or food
- •History or current of drug/ alcohol addiction
- •Bronchial Asthma
- •Epilepsy Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
OCH-NCNP1 3 mg
Active Comparator
干预措施: OCH-NCNP1 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The rate of the patients who identified new or enlarging T2 lesions on MRI scans compared to baseline
时间窗: Change from screening at Month 6.
次要结局
- annual relapse rate(Month 6)
- Detection of asymptomatic(Month 6)
- Change of MRI(Change from screening at Month 3 and 6)
- Duration of sustained reduction in disability (SRD)(Month 6)
- Change of No evidence of disease activity (NEDA)(Change from screening at Month 3 and 6)
- Expanded Disability Status Scale (EDSS) / Functional Scale (FS)(screening, 4weeks, 8 weeks, 12 weeks, 16weeks, 20 weeks, 24 weeks)
研究者
Tomoko Okamoto
Medical director
National Center of Neurology and Psychiatry, Japan
研究点 (1)
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