- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02757079
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders (NPC-15-6)
April 14, 2019 updated by: Nobelpharma
Phase III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders -
The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NPC-15 Granule
NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep latency with electronic sleep diary at week 10.
Time Frame: 10 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep latency with electronic sleep diary at week 26.
Time Frame: 26 weeks
|
To assess the efficacy of this drug in detail
|
26 weeks
|
Abnormal behavior checklist Japanese version
Time Frame: Week 10, 26
|
To assess effects of this drug on neurodevelopment disorders
|
Week 10, 26
|
Adverse events
Time Frame: 28 weeks
|
To assess safety of this drug
|
28 weeks
|
Laboratory findings, vital sign
Time Frame: 28 weeks
|
To assess safety of this drug
|
28 weeks
|
Electro cardiogram
Time Frame: 28 weeks
|
To assess safety of this drug
|
28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2016
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 6, 2018
Study Registration Dates
First Submitted
April 27, 2016
First Submitted That Met QC Criteria
April 27, 2016
First Posted (Estimate)
April 29, 2016
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 14, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Disease
- Sleep Wake Disorders
- Parasomnias
- Neurodevelopmental Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Protective Agents
- Antioxidants
- Melatonin
Other Study ID Numbers
- NPC-15-6
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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