Status:
COMPLETED
Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances
Lead Sponsor:
Neurim Pharmaceuticals Ltd.
Conditions:
Sleep Problems
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief Summary
There is increasing evidence that chronic sleep disorders in children with autism spectrum disorder (ASD), Angelman Syndrome (AS) and Smith-Magenis syndrome (SMS) are associated with disturbed melaton...
Eligibility Criteria
Inclusion
- Subject must be 2 to 17 years old
- 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;
- Subject is able to understand instructions in Dutch.
Exclusion
- 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 occasions;
- 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. -
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01903681
Start Date
March 1 2013
End Date
April 1 2014
Last Update
April 4 2014
Active Locations (1)
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1
Centre for Human Drug Research
Leiden, Netherlands, 2333