EUCTR2015-003147-19-GR进行中（未招募）1 期
ovel Oral Nutraceutical Intervention NEUROASPIS PLP10® for the Treatment of Relapsing-Remitting Multiple Sclerosis: A Multicenter, Parallel-group, Phase III, Double-blind, Randomized, Placebo-Controlled, Add-on with Interferon Beta, Trial of Efficacy and Safety. - Efficacy and Safety study of NEUROASPIS PLP10® versus placebo
PALUPA Medical Ltd0 个研究点目标入组 220 人开始时间: 2016年5月25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
- 220
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
- •Men and women.
- •Ages of between 18 and 55 years.
- •Diagnosis of relapsing remitting Multiple Sclerosis (RRMS) according to revised McDonald criteria.
- •A score of 0.0 to 5.0 on the Expanded Disability Status Scale (EDSS).
- •At least one medically documented relapse within the 18 months before enrolment.
- •Cranial MRI scan demonstrating lesion(s) consistent with MS.
- •On Interferon beta (IFN-ß) treatment for the last 6 continuous months or more.
- •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 220
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior immunosuppressants or monoclonal antibodies therapy (prior or concomitant use of cladribine, mitoxantrone, copaxone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, fingolimod or natalizumab (Tysabri), Tecfidera/BG-12).
- •Prior use in the 3 months preceding randomization, of cytokine therapy, glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments.
- •Consumption of any additional food supplement formula (prior use in the 3 months preceding randomization, of any type of vitamin including vitamin D, or 6 months preceding randomization, of any form of polyunsaturated fatty acid (PUFA), or concomitant use of these treatments).
- •Prior or concomitant use of Statins.
- •Pregnancy or nursing.
- •A clinically significant infectious illness within 30 days prior to randomization.
- •Primary progressive, secondary progressive or progressive relapsing MS.
- •Patients known to have a history of recent drug or alcohol abuse.
- •Any severe disease other than MS compromising organ function, meaning: history of, or abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, renal and/or other major disease, that in the opinion of the investigator, would preclude the administration of NEUROASPIS PLP10® for 30 months.
- •History of severe allergic or anaphylactic reactions or known specific nutritional hypersensitivity.
- •During on intervention treatment it is strongly suggested for the patients to continue only on the interferon beta treatment. If a patient changes therapy to immunosuppressant or monoclonal antibody or fingolimode or any other treatment on physicians’ decision then he/she will be considered as a drop-out; but continue to be medically followed for the intention to treat analyses purposes.
研究者
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