Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders (NPC-15-6)

Nobelpharma Co., Ltd.

Status and phase

Completed

Phase 3

Conditions

Sleep Disorders

Neurodevelopmental Disorder

Treatments

Drug: NPC-15

Study type

Interventional

Funder types

Industry

Identifiers

NCT02757079

NPC-15-6

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.

Full 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.

Enrollment

99 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

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.