Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04233502
Eligibility Criteria:
Inclusion Criteria:
* children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug
* Written informed consent provided by a legal guardian and assent (if needed)
* A documented history of ASD according to or consistent with the ICD 10 or DSM 5 criteria, as confirmed by case note review showing that diagnosis was reached through assessment by a community pediatrician or pediatric neurologist or other health care professionals experienced in the diagnosis who took into account early developmental history and school records.
* Current sleep problems consistent with DSM-5 criteria including: a minimum of 3 months of impaired sleep defined as ≤6 hours of continuous sleep AND ≥ 0.5-hour sleep latency from light off in 3 out of 5 nights based on parent reports and subject medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)
* May be on a stable dose of non excluded medication for 3 months, including anti epileptics, anti depressants (selective serotonin reuptake inhibitor \[SSRIs\]), and β blockers. (Only morning administration of β blockers is allowed since β blockers at night have the potential to reduce endogenous
* The sleep disturbance is not due to the direct physiological effects of any concomitant medications such as SSRIs, β blockers etc.
Exclusion Criteria:
* Have had treatment with any form of melatonin within 2 weeks prior to Visit
* Have a known allergy to melatonin or lactose
* Have a known moderate to severe sleep apnea
* Have an untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances
* Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1
* Are females of child bearing potential that are not using contraceptives and/or breastfeeding and that are sexually active (Abstinence is an acceptable method of contraception.)
* Pregnant females
* Are currently participating in a clinical trial or have participated in a clinical trial involving medicinal product within the last 3 months prior to the study
* Participated in Study NEU\_CH\_7911
* Children with known renal or hepatic insufficiency
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT04233502
Study Brief:
Protocol Section:
NCT04233502