ACTRN12621001413819招募中1 期
A Phase I/II Randomised, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of a Live Biotherapeutic Product (SVT-4A1011) in Adults with Clinically Diagnosed Insomnia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Servatus Ltd
- 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 70 Years（—）
- 性别
- All
入选标准
- •1.Male and female Participants aged 18 to 70 years, capable of providing written informed consent and able to attend the study site on up to 4 separate occasions,
- •2.Insomnia Severity Index (ISI) score greater than or equal to 8 with insomnia symptoms for more than 3 times per week and present for longer than 3 months,
- •3.Clinical diagnosis of Insomnia determined by clinical interview conducted by a trained sleep psychologist,
- •4.Females of childbearing potential (FOCBP) must have a negative pregnancy test at the Baseline Visit. While on the study, FOCBP who engage in activity in which conception is possible, must use one of the approved contraceptive options described below:
- •a.Hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring),
- •b.Intrauterine device (IUD),
- •c.Tubal Ligation,
- •d.Partner’s Vasectomy, or
- •e.Barrier method i.e., male or female condom.
- •5.Male Participants who have not had a vasectomy and who engage in activity in which conception is possible, must use barrier contraception i.e., male condom while on study, or if their partner is FOCBP, the partner can use hormonal contraception, an IUD or have had a tubal ligation.
排除标准
- •1.Sleep apnoea (AHI greater than 10) determined by PSG,
- •2.Medical condition, medication or sleep-related movement disorder that may be causative of the insomnia symptoms,
- •3.Shift-worker working hours between 10pm and 4am,
- •4.History of major psychiatric disorder in the past 12 months, such as severe depression, anxiety or other psychopathologic condition based on self-report or depression scores on the DASS21 greater than or equal to 21 or anxiety scores on the DASS21 greater than or equal to 15, except clinically managed mild depression,
- •5. History of suicide attempt, current suicide ideation or self-harm,
- •6. History of hypersensitivity or severe adverse reaction including but not limited to anaphylaxis to any ingredients in SVT-4A1011,
- •7. Skin sensitivity to adhesive or tape,
- •8. Use of any investigational drug and/or device within 4 weeks of screening or intent to use within the duration of the study,
- •9. History of any infection requiring hospitalisation, parental antimicrobial therapy, or as otherwise judged clinically significant, within the 3 months prior to screening,
- •10.Any prior history of septicaemia or bacteraemia,
- •11. Immunocompromised or those with known or suspected history of immunodeficiency,
- •12. Any condition that, in the opinion of the Study Coordinator or Investigators, contradicts participation in this study or poses an additional risk to the Participant including any known and /or suspected, current or recent history of uncontrolled clinically significant renal, haematological, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease of presence of alarm systems,
- •13. Surgical procedure during the baseline/screening period or for the duration of the study unless deemed by the Study Coordinator to be minor and unlikely to impact on the study,
- •14.A Participant requiring prohibited concomitant medications including prohibited dietary supplements,
- •15.Females who are pregnant or breastfeeding or planning on becoming pregnant for the study period (screening and treatment),
- •16.Excessive caffeine or alcohol use, that in the opinion of the investigator or study delegate, contributes to the participant's insomnia,
- •17.Inability or unwillingness to undergo 2 venepuncture’s (e.g., because of poor tolerability or lack of access to veins),
- •18.Inability or unwillingness to complete the stool collection kits on 2 occasions.
- •19.Positive result on urine drug screen.
研究者
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