EUCTR2016-000118-31-GB进行中（未招募）1 期
A randomised phase II double-blinded placebo-controlled trial of intravenous immunoglobulins and rituximab in patients with antibody-associated psychosis (SINAPPS2) - IVIG and rituximab in antibody-associated psychosis - SINAPPS2
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 80 人开始时间: 2016年11月22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
- 80
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
入选标准
- •To be included in the trial the patient must have:
- •Patient or legal representative is willing and able to provide informed consent.
- •Acute psychosis for at least 2 weeks (defined as symptomatic on the PANSS scale by score equal to or greater than 4 on P1, G9, P3, P2, G5, N1, N4, N6).
- •This may either be a first episode or relapse after remission (remission defined as PANSS=3 on PANSS items P1, G9, P3, P2, G5, N1, N4, N6 for previous 6 months).
- •Serum or CSF neuronal membrane autoantibodies at pathological levels (including NMDAR, LGI1 and other)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •The presence of any of the following will preclude patient inclusion:
- •Duration of current episode of psychosis greater than 24 months.
- •Alternative co-existing severe neurological disease, including tumour, hippocampal sclerosis with refractory epilepsy, probable dementia with evidence of atrophy on brain imaging, moderate or severe learning disability.
- •Any evidence of a current acute encephalopathy (for instance coma, seizures).
- •Hepatitis B, Hepatitis C or HIV positivity; severe hypogammaglobulinaemia.
- •Previous malignancy (to be usually excluded unless agreed with CI).
- •Pregnant, breast feeding or inadequate contraception if female.
- •Hypersensitivity or absolute contra-indication to any study medication, murine proteins or excipients.
- •Live vaccine within last 3 months.
- •Previous treatment with rituximab in the past 12 months.
- •Severe infection and severe heart failure.
- •Any other medical illness or disability that, in the opinion of the investigator, would compromise effective study participation.
- •Concurrent enrolment in other CTIMPs.
研究者
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