Open label, Single Ascending Dose, Cross-over Study to Assess the Pharmacokinetics of Circadin® (Prolonged-Release Melatonin) Mini tablets in Children with Neurodevelopmental disorders and Sleep Disturbances.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

- Subject must be 12-17 years old (extremes inclusive);
- Subject has a documented history of autistic spectrum disorder (ASD; as confirmed according to, DSM-IV-TR 299.00, 299.10 and 299.80 or ICD 10: F 84.0, F84.2, F84.3, F84.5, F84.9 ) or one of the following neurogenetic diseases according to ICD 10: Smith-Magenis syndrome, Angelman syndrome or Tuberous Sclerosis (Bourneville*s disease);
- Subject has current sleep problems; defined as difficulty initiating or maintaining sleep, or non restorative sleep, for at least 1 month (DSM-IV 307.42)
- Subject is able to comply with taking the study drug and collaborate freely with the study procedures;
- Written informed consent from parents having parental responsibility or from the legal guardian(s). In the case of a child is aged 12 years or older the written informed consent of the child is needed in addition to that of parents having responsibility/legal guardian; and
- Subject is able to understand instructions in Dutch.

Exclusion Criteria

- Subject has history of difficulty with swallowing and/or easy choking;
- Subject has current symptoms suggestive of obstructive sleep apnea syndrome or any breathing related sleep disorders or periodic limb movements;
- Subject has known clinically significant disturbance(s) in hepatic and/or renal function;
- Subject has non-stable epileptic attacks within 3 months prior to screening, in case of a history of epilepsy;
- Subject who currently has asthmatic symptoms;
- Subject has untreated medical/psychological condition that may be the etiology of sleep disturbances;
- Subject is unable to refrain from the use of disallowed concomitant medication ordietary supplements (see paragraph 3.4) from 1 week prior to study days;
- Subject is unable to refrain from caffeine-containing products for 24 hours before each occasion;
- Subject has a known allergy to melatonin;
- Female subject who is pregnant at time of screening;
- Subject has unstable use of allowed medication within 2 months prior to the screening;
- Subject has clinically relevant periodontal disease and/or oral injuries as judged by the investigator;
- Subject is unable to refrain from eating bananas and chocolate during the entire day before saliva collection;
- Subject is unable to refrain from drinks containing artificial colorants, caffeine (including but not limited to coffee, tea, cola), or alcohol during the day of the collection;
- Subject is unable to refrain from aspirin or drugs that contain ibuprofen on the collection day;
- Participation in an investigational drug study within 90 days prior to the first dose and/or participation in more than 4 clinical trials in the last year.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- melatonin concentrations in saliva (baseline and after dosing)<br /><br>- 6-SMT (6-sulfatoxymelatonin, a melatonin metabolite) concentrations in urine</p><br>

Secondary Outcome Measures