Sleep DisordersPhase 3NPC-15-6NCT02757079
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
A Phase 3 study testing NPC-15 in people with Sleep Disorders and Neurodevelopmental Disorder, run by Nobelpharma.
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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Sleep Disorders, Neurodevelopmental Disorder
- What is being tested?
- NPC-15
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2016to 6 Jul 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- NPC-15
- Keywords
- Melatonin, NPC-15, Sleep disorders, Neurodevelopmental disorder, Sleep latency, DSM-5
- Medical subject headings
- Sleep Wake Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-15Drug
Also called Melatonin
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.
| Study group | Role | What they receive |
|---|---|---|
| NPC-15 Granule | Experimental | NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed. Receives: Drug: NPC-15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (5)
Sleep latency with electronic sleep diary at week 26.
To assess the efficacy of this drug in detail
Measured: 26 weeks
Abnormal behavior checklist Japanese version
To assess effects of this drug on neurodevelopment disorders
Measured: Week 10, 26
Adverse events
To assess safety of this drug
Measured: 28 weeks
Laboratory findings, vital sign
To assess safety of this drug
Measured: 28 weeks
Electro cardiogram
To assess safety of this drug
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start21 Jun 2016
- Primary completionJul 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yushiro Yamashita, MD, PhD, Principal investigator, The Department of Pediatrics and Child Health Kurume University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757079
- Sponsor's protocol ID
- NPC-15-6
- Acronym
- NPC-15-6
- Status last verified
- Apr 2019
- First submitted
- 27 Apr 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial of NPC-15 - Study of the Efficacy and Safety for Sleep Disorders of Children With Neurodevelopmental Disorders -
- ClinicalTrials.gov ID
- NCT02757079
- Acronym / sponsor ID
- NPC-15-6 / NPC-15-6
- Conditions
- Sleep Disorders, Neurodevelopmental Disorder
- Keywords
- Melatonin, NPC-15, Sleep disorders, Neurodevelopmental disorder, Sleep latency, DSM-5
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPC-15 Granule | Experimental | Drug: NPC-15NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPC-15Also: MelatoninNPC-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. | Drug | NPC-15 Granule |
Primary outcome
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.
5 secondary outcomes
Sleep latency with electronic sleep diary at week 26.
Time frame: 26 weeks
Abnormal behavior checklist Japanese version
Time frame: Week 10, 26
Adverse events
Time frame: 28 weeks
Laboratory findings, vital sign
Time frame: 28 weeks
Electro cardiogram
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yushiro Yamashita, MD, PhD principal investigator
The Department of Pediatrics and Child Health Kurume University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NPC-15 in people with Sleep Disorders and Neurodevelopmental Disorder, run by Nobelpharma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep latency with electronic sleep diary at week 10. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.