Clinical trial NCT02757066: Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
Official title: Phase II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sleep Disorders
Autism Spectrum Disorder
Keywords: Melatonin
NPC-15
Sleep disorders
Autism spectrum disorders
DSM-5
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 196
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep latency with electronic sleep diary
timeFrame: Week 2
Secondary outcomes:
measure: Sleep latency measured by actigraphy
timeFrame: Week 2
measure: Abnormal behavior checklist Japanese version
timeFrame: Week 2, 9
measure: Adverse events
timeFrame: 10 weeks
measure: Electro cardiogram
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The Department of Pediatrics and Child Health Kurume University School of Medicine
name: Yushiro Yamashita, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuge K, Nagamitsu S, Ishikawa Y, Hamada I, Takahashi H, Sugioka H, Yotsuya O, Mishima K, Hayashi M, Yamashita Y. Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders. BMC Psychiatry. 2020 Sep 10;20(1):445. doi: 10.1186/s12888-020-02847-y.