Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders

NCT ID: NCT02757079

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-21
• Study Completion Date: 2018-07-06

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.

Conditions

Sleep Disorders; Neurodevelopmental Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NPC-15 Granule

NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.

Group Type: EXPERIMENTAL

NPC-15

Intervention Type: DRUG

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.

Interventions

NPC-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.

Intervention Type: DRUG

Other Intervention Names

Melatonin

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yushiro Yamashita, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Department of Pediatrics and Child Health Kurume University School of Medicine

Other Identifiers

NPC-15-6

Identifier Type: -

Identifier Source: org_study_id