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

Sleep Disorders Clinical Trial

— NPC-15-6  

Official title:

Phase III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757079
• Other study ID #: NPC-15-6
• Status: Completed
• Phase: Phase 3
• Start date: June 21, 2016
• Est. completion date: July 6, 2018

Study information

• Verified date: April 2019
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 6, 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Neurodevelopmental Disorder
• Neurodevelopmental Disorders
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep latency with electronic sleep diary at week 10.	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.	10 weeks
Secondary	Sleep latency with electronic sleep diary at week 26.	To assess the efficacy of this drug in detail	26 weeks
Secondary	Abnormal behavior checklist Japanese version	To assess effects of this drug on neurodevelopment disorders	Week 10, 26
Secondary	Adverse events	To assess safety of this drug	28 weeks
Secondary	Laboratory findings, vital sign	To assess safety of this drug	28 weeks
Secondary	Electro cardiogram	To assess safety of this drug	28 weeks