ACTRN12606000037505已完成2 期
A Multicentre, phase IIa clinical trial to assess the safety, tolerability and pharmacodynamics of Cpn10 administered as multiple intrvenous injections in volunteers with multiple sclerosis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CBio Limited
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Have a diagnosis of MS, as defined by the McDonald criteria. 2. Have either relapse/remitting or secondary progressive disease. 3. Have a Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 6.5. 4.Have an abnormal MRI at initial assessment, as defined by the Paty criteria, i.e. greater than 4 lesions, or 3 lesions of which 1 is periventricular. 5. Patients with adequate venous access in their left or right arm to allow collection of a number of blood samples via a venepuncture. 6. Fluent in the English language. 7. Have voluntarily given written informed consent to participate in this study.
排除标准
- •1. Other definable cause for clinical presentation (i.e. not MS).2. Primary progressive disease course.3. Clinically isolated syndrome even when sufficient paraclinical evidence to meet McDonald criteria for a diagnosis of MS.4. Normal MRI brain at initial assessment (Paty criteria).5. Exacerbation in 28 days prior to treatment onset (i.e. during 4 week lead-in time).6. Administration of any other disease modifying therapy in the preceding 3 months (beta-interferon 1a, beta-interferon 1b, glatiramer acetate, azathioprine, mitoxantrone, prednisolone, methylprednisolone or other steroid agent).7. Except for any primarily immunomodulatory drugs, standard drugs with minor immunological effects (e.g. tricyclic antidepressants), including illicit drugs, will be allowed at the Investigator's discretion.8. Other severe illness that might interfere with assessment or hamper patients ability to complete the study.9. Abnormal haematological or biochemical parameters at initial assessment or study onset (based on reference ranges from the diagnostic facility); exclusion will be at the Investigator's discretion.10. Anti-nuclear antibody (ANA) titre of 1 in 80 or greater at screening.11. Positive pregnancy test at initial assessment or study onset.12. Unwilling or unable to take adequate contraceptive precautions for the period of the study.13. History of any psychiatric illness which may impair the ability to provide written informed consent.14. Poor compliers or those unlikely to attend.15. Inability to have MRI scans, based on completion of a standard questionnaire by each patient at screening. Specifically:(a) Contraindication to MR scanning (absolute and relative)i. Cardiac pacemaker or retained pacemaker leadsii. Cerebral aneurysm clipsiii. Implanted neuro-stimulators or electronic devices, including Cochlear implantiv. History of penetrating eye injuryv. Schrapnel(b) Claustrophobia16. Inability to receive Gadolinium injections for MRI scans, due to:(a) Previous sensitivity to Gadolinium(b) Lactating(c) Known iron overload(d) Sickle cell anaemia(e) Haemolytic anaemia(d) Thalassaemia17. Participation in a clinical trial, or has received any experimental therapy, within the last 30 days.18. Donated or lost a significant amount of blood (e.g. 550 mL) within the past 12 weeks.
研究者
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