ACTRN12620001254987招募中2 期
A Phase 2 Randomised Controlled Trial of Sodium Selenate as aDisease Modifying Treatment for Probable Progressive SupranuclearPalsy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
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
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female (aged 40 years or over). All participants of reproductive potential must be using effective contraception for the duration of the trial and for 4 weeks following cessation of the investigational medicinal product (IMP). Female participants of non-childbearing potential must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal at least 1 year. All female participants must have a negative plasma hCG pregnancy test at screening.
- •2 Subjects must have a diagnosis of Probable PSP established in accordance with the MDS Criteria (Hoglinger et al., 2017).
- •3. Subjects must have a lumbar puncture performed within 14 days prior to Baseline (Visit 2).
- •4. Subjects must have an MRI scan during the screening period and prior to Baseline (Visit 2), with no gross structural abnormality indicative of a neurological disorder other than PSP.
- •5. Subjects must be able to walk a minimum of 5 steps with minimal assistance (walker allowed).
- •6. Subjects must be living in the community and have at least 10 contact hours per week with a responsible carer. The carer should be capable of ensuring the subject's compliance with the medication, be prepared to attend with the subject for assessment and be willing to participate in completing the various assessments throughout the period of the subject’s involvement in the Study.
- •7. Written informed consent must be obtained from the subject or legally authorised representative (as required by local laws and regulations), and the participant’s carer.
排除标准
- •1. Subject has participated in a clinical investigation of a medication or device within the 3 months prior to the Screening Visit (Visit 1).
- •2. Subject in whom a lumbar puncture is contra-indicated.
- •3. Subject has a history of alcohol and/or drug abuse, defined as meeting DSM-V criteria for substance use disorder. This applies to alcohol and/or any illicit drug, including cannabis within the 6 months prior to the Screening Visit (Visit 1).
- •4. Subject who is unlikely to comply with trial visit schedule or with trial medication.
- •5. Subject has a known sensitivity to selenium or sodium selenate or any medicine or vitamin containing sodium selenate, similar agents or any of the excipients (including microcrystalline cellulose) used.
- •6. Subject has current evidence or history of neurological, psychiatric or any other illness that could contribute to PSP-like symptoms.
- •7. Subject has a known history of familial Alzheimer’s Disease.
- •8. Subject has a known genetic variant that confers likelihood of another neurodegenerative condition (eg C9Orf72, PSEN1, SYNJ1, PRNP).
- •9. Subject has a significant medical disease, with the exception of PSP that:
- •a) is not adequately controlled by therapy; and/or
- •b) in the opinion of the investigator may interfere with the patient’s ability to complete the study or might impact on the patient’s PSP symptoms
- •10. Subject has current evidence of unstable diabetes.
- •11. Subject has significant impairment of any of the following for the age of the subject, which may compromise safety of the subject/validity of the data:
- •a) Renal function (i.e. estimated glomerular filtration rate (eGFR) less than 30)
- •b) Hepatic function (i.e. abnormal liver function tests greater than 2 x upper limit of normal)
- •c) Haematological function.
- •12. Subject in whom it is anticipated that there will be a definite indication for the commencement of other licensed drug for the treatment of PSP symptoms within the 64-
- •week period of trial participation.
- •13. Subject is currently taking any of the following: Carbamazepine, digoxin, phenobarbitone, warfarin or any other medication that has a narrow margin between effective dose and toxic dose or between effective dose and ineffective dose, where the subject would be at risk if the levels were elevated or fell due to interaction with sodium selenate.
- •14. Subject has started taking other medication known to have an effect on movement, mood or cognition within the 4 weeks prior to the Screening Visit (Visit 1); or has changed their dose of these medications within the 6 weeks prior to the Screening Visit (Visit 1).
- •Examples of such drugs include:
- •a) Dopaminergic drugs (leva-dopa, COMT inhibitors, amantadine)
- •b) Anticholinergics, for example ipratropium, oxitropium or tiotropium bromide
- •c) Hypnotics, sedatives and anxiolytics, for example barbiturates, benzodiazepines, serotonin 1A agonists, hydroxyzine, zolpidem or zopiclone
- •d) Antidepressants, for example tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitor (MAOIs), serotoninnorepinephrine reuptake inhibitors (SNRIs), noradrenergic and specific serotonergic antidepressants, buspirone, reboxetine or trazodone
- •e) Antiepileptics, for example barbiturates, benzodiazepines, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, primidone, topiramate, valproate or vigabatrin
- •f) Antipsychotics, for example butyrophenones, phenothiazines, thioxanthenes, amis
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