A study investigating if Circadin (compared to placebo) helps children with neurodevelopmental disabilities to better sleep

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 267

Inclusion Criteria

To be eligible for study entry, all patients must satisfy all of the following criteria at screening.
1. Must be children 2 to 17.5 years of age at Visit 2 who comply with taking the study drug.
2. Must have written informed consent provided by a legal guardian and assent (if needed).
3. Must have a documented history of ASD according to ICD-10 or DSM-5/4 or neurodevelopmental disabilities caused by neurogenetic diseases (Smith-Magenis syndrome [SMS], Angelman syndrome, Bourneville’s disease [tuberous sclerosis]) as confirmed by case note review showing that diagnosis was reached through assessment by a community paediatrician or paediatric neurologist or other health care professionals experienced in the diagnosis, who took into account early developmental history and school records.
4. Must have current sleep problems including: A minimum of 3 months of impaired sleep defined as =6 hours of continuous sleep and/or = 0.5 hour sleep latency from light off in 3 out of 5 nights based on parent reports and patient medical history. (The maintenance and latency problems do not necessarily have to be in the same 3 nights of the week.)
5. May be on a stable dose of non-excluded medication for 3 months, including anti-epileptics, anti-depressants (SSRIs), stimulants, all mood changing drugs and beta blockers.
6. The sleep disturbance is not due to the direct physiological effects of the medication (SSRIs, stimulants, etc.).
At the end of 4 weeks of sleep hygiene training (for those who need it) and 2 weeks of run-in, children will be eligible to continue the study if they comply with the following:
1. Continue to fulfil sleep problem criteria (see Inclusion Criterion 4).
2. Parents demonstrate compliance in Sleep and Nap Diary completion (5 out of 7 nights).
3. Continue to fulfil all other eligibility criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
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

Exclusion Criteria

1. Have had treatment with any form of melatonin within 2 weeks prior to Visit 1.
2. Have a known allergy to melatonin or lactose.
3. Have a known moderate to severe sleep apnea.
4. Have untreated medical/ineffectively treated/psychological condition that may be the etiology of sleep disturbances.
5. Did not respond to previous Circadin therapy based on past medical history records in the last 2 years.
6. Are taking or have been taking prohibited medication within 2 weeks prior to Visit 1.
7. Are females of child bearing potential that are not using contraceptives and/or are breastfeeding and that are sexually active (Abstinence is an acceptable method of contraception).
8. Pregnant females
9. 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 (this does not include patients who participated in the Phase I PK study who can be already included in the study) .
10. Children with known renal or hepatic insufficiency

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

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