EUCTR2016-000700-29-SE进行中（未招募）1 期
Effect of MD1003 in progressive multiple sclerosis: a randomized-double blind placebo-controlled study. - SPI2
MEDDAY PHARMACEUTICALS SA0 个研究点目标入组 766 人开始时间: 2016年11月14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
- 766
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
- •1. Patient aged 18-65 years old
- •2. Signed and dated written informed consent form in accordance with local regulations: having freely given their written informed consent to participate in the study
- •3. Diagnosis of primary or secondary progressive MS fulfilling revised McDonald criteria (2010) and Lublin criteria (2014)
- •4. Documented evidence of clinical disability progression within the 2 years prior to inclusion, i.e. a) progression of EDSS during the past two years of at least 1 point sustained for at least 6 months if inclusion EDSS is from 3.5 to 5.5 or at least 0.5 point increase sustained for at least 6 months if inclusion EDSS is from 6 to 6.5 or b) increase of TW25 by at least 20% in the last two years sustained for at least 6 months or c) other well-documented objective worsening validated by the Adjudication Committee
- •5. EDSS at inclusion from 3.5 to 6.5
- •6. TW25 < 40 seconds
- •7. Kurtzke pyramidal functional subscore =2 defined as minimal disability: patient complains of motor-fatigability or reduced performance in strenuous motor tasks (motor performance grade 1) and/or BMRC grade 4 in one or two muscle groups”
- •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 745
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1. Clinical evidence of a relapse in 24 months prior to inclusion
- •2. Treatment with any product containing biotin as single ingredient within six months prior to inclusion (multivitamin supplementation authorized if biotin < 1mg per day)
- •3. Concomitant treatment with fampridine at inclusion or in the 30 days prior to inclusion
- •4. New immunosuppressive/immunomodulatory drug initiated less than 90 days prior to inclusion
- •5. Treatment with botulinium toxin (except for cosmetic purpose) initiated within 6 months prior to inclusion
- •6. In-patient rehabilitation program within the 3 months prior to inclusion
- •7. Pregnancy, breastfeeding or women with childbearing potential without acceptable form of contraception
- •8. Men unwilling to use an acceptable form of contraception
- •9. Any general chronic handicapping/incapacitating disease other than MS
- •10. Any serious disease necessitating biological follow-up with biological tests using biotinylated antibodies or substrates
- •11. Past history of rhabdomyolysis/metabolic myopathy
- •12. Known fatty acids beta oxidation defect
- •13. Known hypersensitivity or intolerance to biotin, analogues or excipients, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •14. Patients with hypersensitivity or any contra-indication to Gadolinium
- •15. Patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or cancer
- •16. Laboratory tests out of normal ranges considered by the investigator as clinically significant with regards to the study continuation
- •17. Patients with history or presence of alcohol abuse or drug addiction
- •18. Untreated or uncontrolled psychiatric disorders, especially suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
- •19. Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use during the study duration
- •20. Patients likely to be non-compliant to the study procedures or for whom a long-term follow-up seems to be difficult to achieve
- •21. Relapse that occurs between inclusion and randomization visit
研究者
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