EUCTR2013-002515-10-DE进行中（未招募）1 期
Treatment of Optic Neuritis with Erythropoietin: a randomised, double-blind, placebo-controlled trial - TONE
niversity Medical Center Freiburg0 个研究点目标入组 108 人开始时间: 2014年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
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. Written informed consent obtained according to international guidelines and local laws
- •2. Male and female patients aged = 18 to = 50 years
- •3. Patients with optic neuritis
- •4. First symptoms of optic neuritis = 10 days prior to the first administration of investigational product
- •5. High contrast visual acuity (HCVA) of = 0.5 (decimal system)
- •6. Adequate Optical Coherence Tomography (OCT) measurements available
- •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 108
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
- •2. Simultaneous participation in another interventional trial which could interfere with this trial and/or participation in a clinical trial within the last 3 months before enrolment in this trial
- •3. Refractive anomalies: Hyperopia > 5 dpt, myopia < -7 dpt, astigmatism > 3 dpt
- •4. Media opacity
- •5. Severe papillitis
- •6. Previous ON
- •7. Any other optic nerve and retinal disease
- •8. Pre-existing MS or any other neurological disease
- •9. Congenital diseases:
- •thrombophilia
- •phenylketonuria
- •10. Acquired diseases:
- •autoimmune diseases,
- •cardiovascular diseases,
- •diabetes mellitus,
- •uncontrolled hypertension (with blood pressure > 140 / 90 mm Hg),
- •any malignancy,
- •epilepsy,
- •known tuberculosis with ongoing or unknown activity,
- •acute gastrointestinal ulceration within the last 3 months prior to randomisation,
- •acute viral, bacterial or fungal infection,
- •known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis C Virus,
- •history of colitis ulcerosa, diverticulitis, or acute enteroanastomosis,
- •known osteoporosis,
- •history of thromboembolic events,
- •elevated haemoglobin level (>17 g/dl in men or >15 g/dl in women),
- •polycythaemia
- •any other significant illness potentially interfering with any trial assessment or treatment
- •11. Performing semi-professional or professional sporting activities or physical training
- •12. Pre-treatment with corticosteroids in the last 30 days prior to the onset of optic neuritis
- •13. Pre-treatment with EPO
- •14. Known or persistent abuse of medication, drugs or alcohol
- •15. Active immunization within 2 weeks prior to randomisation
- •16. Significant surgery within 4 weeks prior to randomisation
- •17. Blood donation or bloodletting within 4 weeks prior to screening
- •18. Pre-treatment with immunosuppressive or immunomodulatory agents
- •19. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
- •Additional specific exclusion criteria for female patients who are able to have a child
- •20. Current or planned pregnancy, nursing period within 3 months from investigational product administration
- •21. Unwillingness to use one of the following safe combination methods of contraception within 3 months from investigational product administration to achieve a PEARL index of <1: female condom, diaphragm or coil, each used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
研究者
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