Neurodevelopmental Disorder, Sleep Disorders
Conditions
Keywords
Melatonin, NPC-15, Sleep disorders, Neurodevelopmental disorder, Sleep latency, DSM-5
Brief summary
The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.
Detailed description
This study will be a multicenter and open label trial. The trial has three phases; the screening phase, treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During open label treatment phase, all patients will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.
Interventions
DRUGNPC-15
NPC-15, Melatonin granule 1 mg, 2 mg or 4 mg, once a day, is administered orally before going to bed for 26 weeks after a screening phase of 2 weeks with placebo administration.
Sponsors
Nobelpharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Female or male patients aged 6 to 15 years. * Patients with neurodevelopmental disorder diagnosed by using DSM-5. * Patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months * Patients who are out-patient, not hospitalized patient. * Signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed IC or informed assent obtained from the patient themselves.
Exclusion criteria
* Patients with at least severity in either Conceptual area, or Social area, or Practical area of intellectual disability have judged more than the most severe by using DSM-5. * Patients who took melatonin (including supplement) in history. * Patients who had taken Ramelteon within 4 weeks before clinical study starts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep latency with electronic sleep diary at week 10. | 10 weeks | Sleep latency is a common endpoint in sleep disorders. In addition, it has been used in a randomized clinical study of sleep disorders of children with neurodevelopmental disorders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep latency with electronic sleep diary at week 26. | 26 weeks | To assess the efficacy of this drug in detail |
| Abnormal behavior checklist Japanese version | Week 10, 26 | To assess effects of this drug on neurodevelopment disorders |
| Adverse events | 28 weeks | To assess safety of this drug |
| Laboratory findings, vital sign | 28 weeks | To assess safety of this drug |
| Electro cardiogram | 28 weeks | To assess safety of this drug |
Outcome results
None listed