EUCTR2016-004739-19-NO进行中（未招募）1 期
OSU6162 IN THE TREATMENT OF FATIGUE AND OTHER NEUROPSYCHOLOGICAL SEQUELAE AFTER ANEURYSMAL SUBARACHNOIDAL HEMORRHAGE - A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED STUDY
Oslo University Hospital0 个研究点目标入组 100 人开始时间: 2017年2月1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
- 100
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.Signed written informed consent
- •2.> 18 years old
- •3.Aneurysmal subarachnoid haemorrhage >12 months prior to the start of the study.
- •4.Diagnosed with post SAH syndrome/fatigue at =12 months after their hemorrhage
- •5.Post-menopausal or using adequate contraceptive measures
- •-Female patients of childbearing potential using a highly efficient method of contraception (i.e. a method with a failure rate of less than 1% [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, or vasectomy in partner])
- •-Male patients agreeing to use condoms during the study and for 3 months after the end of the study/last dose of the investigational medicinal product, or male patients with a partner who is using a highly efficient method of contraception (as described above)
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Residual symptoms following other pathologies than aSAH
- •2.Not adequately treated hydrocephalus secondary to aSAH
- •3.Diagnosed with neurodegenerative disease
- •4.Active substance abuse (drug screen taken at baseline)
- •5.Current pregnancy or breast-feeding, or intention to become pregnant within 3 months after the last dose
- •6.Women of childbearing age not using contraceptives
- •7.Pathologic ECG, as assessed by the investigator. Max QTc-time on ECG: 450 ms in men and 460 ms in women
- •8.Abnormal laboratory values of such severity that participation in the study, in the opinion of the investigator, is questionable
- •9.Patients who are so debilitated by their disease that they are not assumed to be able to perform the assessments or handle the instruments used for evaluation of effect and/or are not able to consent
- •10.Patients that speak so poorly Norwegian that they are not able to answer the questionnaires or undergo neuropsychological testing
- •11.Previous treatment with OSU6162
- •12.Clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in either total bilirubin, alkaline phosphatase, LDH, SGOT of >2 times the laboratory reference
- •13.Clinically significant renal disease which may prevent the patient from completing the study and/or an elevation in serum creatinine of >1.5 times the laboratory reference.
- •14.Any surgical or medical condition which, in the opinion of the investigator, might interfere with the absorption, distribution, metabolism or excretion of OSU6162
- •15.Patients treated with Modiodal, Xyrem, Mirtazapine, Mianserin or metabolic enzyme inhibitors or inducers, or drugs with a narrow treatment window (e.g. warfarin, antiepileptics, cyclosporine) and individually modelled drugs such as lithium
- •16.Use of drugs capable of inducing hepatic enzyme metabolism (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone) within 30 days prior to the start of the study (or 5 half-lives of the inducing agent, whichever is longer)
- •17.Antipsychotic treatment
- •18.Patients treated with unstable therapies”, i.e., treatments that have not been at the same dose for at least 6 weeks prior to inclusion in this study. The treatment must also remain unchanged during the study period. Insomnia medication and other PRN medications are allowed.
- •19.Use of acute or chronic medications for other medical conditions are allowed based on the investigator’s judgement. Occasional use of over-the-counter (OTC) medication is not allowed during the study or one month prior to inclusion.
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