Clinical research study to determine how trazodone can influence the sleep and how it works in the body after one or repeated doses taken by mouth, in children suffering from insomnia and with autism, intellectual disability or attention deficit hyperactivity disorder (ADHD)
- Conditions
- Insomnia in children and adolescents with autism, intellectual disability or ADHDMedDRA version: 20.0Level: PTClassification code 10022443Term: Insomnia related to another mental conditionSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-001166-42-IT
- Lead Sponsor
- AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
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: 1
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
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 previous 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 containing) – hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, 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 is adolescent male who is sexually active and unwilling or unable to use a condom as contraception method throughout the duration of the study and 1 month following study completion
12. Patient is adolescent male who is sexually abstinent and does not agree to continue practicing abstinence or to use a condom as contraception method throughout the duration of the study and 1 month following study completion.
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 comprehen
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method