EUCTR2018-001166-42-ES进行中（未招募）1 期
A multi-centre, randomized, parallel-group, single blind Phase II trial to evaluate the pharmacokinetics and PKPD relationship of trazodone after single and repeated oral doses in children from 2 to = 17 years of age, suffering from insomnia, with autism, intellectual disability or attention deficit hyperactivity disorder (ADHD)
Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.A (Angelini S.p.A.)0 个研究点目标入组 36 人开始时间: 2018年8月7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
- 36
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. Patient provided a signed written informed consent (including personal data processing) by parents/legal guardian
- •2. Patient with documented assent by patient in accordance with age and maturity level, in line with 2017 ethical considerations for clinical trials on medicinal products conducted with minors
- •3. Patient is male or female, 2-17 years of age (inclusive)
- •4. Patient diagnosed with autism, intellectual disability or ADHD according to ICD-10 (F84.0, F90.9, F79) or DSM-5 (299.00, 314.01, 319) criteria
- •5. Patient diagnosed with insomnia according to ICSD-3 (American Academy of Sleep Medicine, 2014) criteria
- •6. Sleep disturbance scale for children with a total score > 60
- •7. Patient on a stable therapy for their primary neurodevelopmental disorders (NDDs), apart from medications specified in the ‘exclusion criteria’
- •8. Patient taking any sleep-inducing medication has completed the required wash-out period of 7 days
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient with ascertained or presumptive hypersensitivity to trazodone and/or its excipients
- •2. Patient with history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
- •3. Patient treated with any form of trazodone within 2 weeks prior to the inclusion in the study
- •4. Patient not responding to previous trazodone-based therapy based on past medical history records in the last 2 years
- •5. Patient taking any medications (except those foreseen for their primary NDDs) that prolong the QT/corrected QT interval or included in the Interactions with other medicinal products and other forms of interaction” of trazodone Summary of Product Characteristics within 2 weeks before the start of the study and during the study duration
- •6. Patient is female affected by Rett syndrome
- •7. Patient with a diagnosis of HIV, hepatitis B virus surface antigen or hepatitis C virus
- •8. For female patient: pregnancy or lactation
- •9. Patient is adolescent female of childbearing potential who is sexually active and unwilling or unable to use an highly effective birth control method, which includes combined – estrogen and progestogen – hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence for at least 1 month prior to study entry, throughout the duration of the study and 1 month following study completion
- •10. Patient is adolescent female of childbearing potential who is sexually abstinent and does not agree to continue practicing abstinence or to use one of the highly effective birth control methods should her sexual activity commence
- •11. Patient participating in the evaluation of any investigational product for 3 months before this study (the 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study [i.e. screening visit])
- •12. Patient is first-degree relative of any of the members of the team involved in the conduct of the study
- •13. Patient with corrected QT interval using Fridericia´s formula (QTcF) value =440 msec for male and =450 msec for female, for all age groups
- •14. Patient with history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome, cardiac arrhythmias, bradycardia, cardiac conduction abnormalities, cardiac hypertrophy, cardiomyopathy, chronic cardiac insufficiency)
- •15. Patient with evident history of drug and/or alcohol abuse in adolescents (12 to = 17 years of age)
- •16. Patient with physical abnormalities or clinically significant abnormal laboratory test results relevant for the study assessments or the patient’s safety
- •17. Patient with history of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study
- •18. Patient with history of blood loss exceeding 3% of the patient’s total blood volume within 1 month before the study
- •19. Patient with any condition (surgical or medical) which will affect absorption, distribution, metabolism and/or excretion of the drug
- •20. Patient and parents/legal guardian, who are unable to comprehend the full nature and purpose of the study and to comply with the
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