EUCTR2014-000221-20-AT进行中（未招募）1 期
Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial
niversity Hospital Zürich0 个研究点目标入组 16 人开始时间: 2014年6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
- 16
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
- •Clinically isolated Syndrome or Relapsing-remitting MS (45, 46)
- •Age 18 to 55 years inclusive
- •EDSS at screening = 5.5.
- •Disease duration = 10 years
- •Patients are not eligible for standard therapies, or opted not to start or continue with any of the standard therapies.
- •Patients are able to provide signed informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
- •To be eligible to proceed to the treatment phase of the study, patients must have = two CELs in the three sequential baseline MRI scans (average of =0.66 CELs).
- •Patients cannot have a relapse during 30 days before initiation of treatment. If a relapse occurs during this period and eligibility criteria are otherwise fulfilled, treatment (day one) will be delayed until at least 30 days after receiving steroids. If corticosteroids are administered, the MRI during that period will not be considered. An additional MRI will be added at 4 weeks following the completion of corticosteroids, to maintain a total of three MRIs that are analyzed in the baseline period. In the event of relapse, the baseline period will be prolonged, as necessary, to meet these criteria.
- •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 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Diagnosis of secondary-progressive or primary-progressive MS, as defined by published diagnostic criteria (46).
- •Abnormal screening/baseline blood tests exceeding any of the limits defined below:
- •Serum alanine transaminase or aspartate transaminase levels, which are greater than three times the upper limit of normal values.
- •Total white blood cell count < 3 000/mm3
- •Platelet count < 85 000/mm3
- •Serum creatinine level > 2.0 mg/dl, if serum creatinine level > 1.2 mg/dl, glomerular filtration rate must be determined, patients are excluded if it is <30ml/minute
- •Positive pregnancy test
- •Any other significant clinical abnormality
- •Pregnant or breast-feeding female.
- •History or signs of immunodeficiency.
- •Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.
- •Inability to complete an MRI (contraindications for MRI include but are not restricted to known allergy to gadolinium contrast dyes, renal impairment which would contraindicate gadolinium injection, claustrophobia, weight =o140 kg, pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.).
- •Patients with cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
- •If prior treatments were administered, the patient must be off treatment for the required period prior to enrollment as defined in the protocol.
- •Prior treatment with other investigational drugs or procedures will be evaluated individually by the investigators.
- •History of alcohol or drug abuse within the 5 years prior to enrolment.
- •Female patients who are not post-menopausal or surgically sterile who are not using an acceptable method of contraception. Acceptability of various methods of contraception will be at the discretion of the investigator. Documentation that the patient is post-menopausal or surgically sterile must be available prior to enrolment.
- •Male patients who are not surgically sterile and not practicing adequate contraception. Acceptability of various methods of contraception will be at the discretion of the investigator and will be discussed in details with all male patients during the informed consent procedure. Documentation that the patient is surgically sterile must be available prior to enrolment.
- •Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule.
- •Previous participation in this study.
- •Enrolment of the investigator, his/her family members, employees and other dependent persons.
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