Autism Spectrum Disorder, Sleep Disorders
Conditions
Keywords
Melatonin, NPC-15, Sleep disorders, Autism spectrum disorders, DSM-5
Brief summary
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
Detailed description
This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. 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 Granules Lower Dose
NPC-15 granule which contains 1mg melatonin
DRUGNPC-15 Granules Higher Dose
Melatonin granule which contains 4 mg melatonin
DRUGNPC-15 Placebo Granule
Melatonin placebo granule which does not contains melatonin.
Sponsors
Nobelpharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 autism spectrum 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 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 | Week 2 | 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 |
|---|---|---|
| Adverse events | 10 weeks | To assess safety of this drug |
| Electro cardiogram | 10 weeks | To assess safety of this drug |
| Sleep latency measured by actigraphy | Week 2 | To assess the efficacy of this drug in detail |
| Abnormal behavior checklist Japanese version | Week 2, 9 | To assess effects of this drug on neurodevelopment disorders |
Outcome results
None listed