Back to resultsStudy of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders (NPC-15-6)
Primary Purpose
Sleep Disorders, Neurodevelopmental Disorder
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
NPC-15
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disorders focused on measuring Melatonin, NPC-15, Sleep disorders, Neurodevelopmental disorder, Sleep latency, DSM-5
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NPC-15 Granule
Arm Description
NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Sleep latency with electronic sleep diary at week 26.
To assess the efficacy of this drug in detail
Abnormal behavior checklist Japanese version
To assess effects of this drug on neurodevelopment disorders
Adverse events
To assess safety of this drug
Laboratory findings, vital sign
To assess safety of this drug
Electro cardiogram
To assess safety of this drug
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02757079
Brief Title
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
Acronym
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 -
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Neurodevelopmental Disorder
Keywords
Melatonin, NPC-15, Sleep disorders, Neurodevelopmental disorder, Sleep latency, DSM-5
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NPC-15 Granule
Arm Type
Experimental
Arm Description
NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.
Intervention Type
Drug
Intervention Name(s)
NPC-15
Other Intervention Name(s)
Melatonin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep latency with electronic sleep diary at week 10.
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Sleep latency with electronic sleep diary at week 26.
Description
To assess the efficacy of this drug in detail
Time Frame
26 weeks
Title
Abnormal behavior checklist Japanese version
Description
To assess effects of this drug on neurodevelopment disorders
Time Frame
Week 10, 26
Title
Adverse events
Description
To assess safety of this drug
Time Frame
28 weeks
Title
Laboratory findings, vital sign
Description
To assess safety of this drug
Time Frame
28 weeks
Title
Electro cardiogram
Description
To assess safety of this drug
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yushiro Yamashita, MD, PhD
Organizational Affiliation
The Department of Pediatrics and Child Health Kurume University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
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