ISRCTN06166891已完成3 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
Ministry of Commerce, Industry and Tourism (Cyprus)0 个研究点目标入组 200 人开始时间: 2013年3月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23599375 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36353267/ (added 11/11/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Men and women
- •2. Aged between 18 and 55 years
- •3. Diagnosis of relapsing remitting multiple sclerosis (RRMS) according to revised McDonald criteria
- •4. A score of 0.0 to 5.0 on the Expanded Disability Status Scale (EDSS)
- •5. At least one medically documented relapse within the 18 months before enrolment
- •6. Cranial MRI scan demonstrating lesion(s) consistent with MS
- •7. On interferon beta (IFN-ß) treatment for the last 6 continuous months or more
- •Note: If a clinical documented relapse (see primary outcomes) is reported during the 'normalization' period the entry baseline EDSS for that patient will be reported as the EDSS score documented at least 4 weeks after the last relapse during this period.
排除标准
- •1. 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]) or Tecfidera/BG-12)
- •3. Prior use in the 3 months preceding randomization of cytokine therapy, glatiramer acetate or intravenous immunoglobulins, or concomitant use of these treatments
- •3. Pregnancy or nursing
- •4. A clinically significant infectious illness within 30 days prior to randomization
- •5. Primary progressive, secondary progressive or progressive relapsing MS
- •6. Patients known to have a history of recent drug or alcohol abuse
- •7. 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 PLP10 for 30 months.
- •8. History of severe allergic or anaphylactic reactions or known specific nutritional hypersensitivity.
- •As of 31/03/2016 the following exclusion criteria have been added:
- •9. 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)
- •10. Prior or concomitant use of statins
- •Note: During 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 will continue to be medically followed for the purpose of the intention-to-treat analyses.
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