Sleep disorders Insomnia sleep disoder
Conditions
Interventions
Single dose of 2 mg (2 mini-tablets) and 10 mg (10 mini-tablets) Circadin®
prolonged-release melatonin formulation, with minimum of 7 days wash-out.
Sponsors
Neurim Pharmaceuticals Ltd.
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - melatonin concentrations in saliva (baseline and after dosing) - 6-SMT (6-sulfatoxymelatonin, a melatonin metabolite) concentrations in urine | — |
Secondary
| Measure | Time frame |
|---|---|
| - safety (adverse events) - feasibility of this type of trial in this patient population | — |
Countries
Netherlands
Outcome results
None listed