Sleep DisordersPhase 2/3NPC-15-5NCT02757066
Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders
A Phase 2/3 study testing NPC-15 Granules Lower Dose and NPC-15 Granules Higher Dose in people with Sleep Disorders and Autism Spectrum Disorder, run by Nobelpharma.
Trial summary
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Sleep Disorders, Autism Spectrum Disorder
- What is being tested?
- NPC-15 Granules Lower Dose and NPC-15 Granules Higher Dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 16 Jun 2016to 14 Sep 2018
- Phase
- Phase 2/3
- 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 "autism spectrum 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 "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 II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -
The purpose of this study is to verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
Read the detailed description
This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. 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, Autism Spectrum Disorder
- Being tested
- NPC-15 Granules Lower Dose, NPC-15 Granules Higher Dose, NPC-15 Placebo Granule
- Keywords
- Melatonin, NPC-15, Sleep disorders, Autism spectrum disorders, DSM-5
- Medical subject headings
- Sleep Wake Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPC-15 Granules Lower DoseDrug
Also called Melatonin 1mg
NPC-15 granule which contains 1mg melatonin
NPC-15 Granules Higher DoseDrug
Also called Melatonin 4mg
Melatonin granule which contains 4 mg melatonin
NPC-15 Placebo GranuleDrug
Also called Placebo
Melatonin placebo granule which does not contains melatonin.
| Study group | Role | What they receive |
|---|---|---|
| NPC-15 Granules Lower Dose | Experimental | NPC-15 Granules Lower Dose group which is administered 1mg melatonin Receives: Drug: NPC-15 Granules Lower Dose |
| NPC-15 Granules Higher Dose | Experimental | NPC-15 Granules Higher Dose group which is administered 4 mg melatonin Receives: Drug: NPC-15 Granules Higher Dose |
| NPC-15 Placebo Granule | Placebo comparator | NPC-15 Placebo Granules group which is administered placebo melatonin Receives: Drug: NPC-15 Placebo Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep latency with electronic sleep diary
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: Week 2
Secondary outcomes (4)
Sleep latency measured by actigraphy
To assess the efficacy of this drug in detail
Measured: Week 2
Abnormal behavior checklist Japanese version
To assess effects of this drug on neurodevelopment disorders
Measured: Week 2, 9
Adverse events
To assess safety of this drug
Measured: 10 weeks
Electro cardiogram
To assess safety of this drug
Measured: 10 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 start16 Jun 2016
- Primary completionSep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 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
- NCT02757066
- Sponsor's protocol ID
- NPC-15-5
- Acronym
- NPC-15-5
- 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
Publications
Yuge K, Nagamitsu S, Ishikawa Y, Hamada I, Takahashi H, Sugioka H, Yotsuya O, Mishima K, Hayashi M, Yamashita Y. Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders. BMC Psychiatry. 2020 Sep 10;20(1):445. doi: 10.1186/s12888-020-02847-y.
PubMed 32912180
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 II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -
- ClinicalTrials.gov ID
- NCT02757066
- Acronym / sponsor ID
- NPC-15-5 / NPC-15-5
- Conditions
- Sleep Disorders, Autism Spectrum Disorder
- Keywords
- Melatonin, NPC-15, Sleep disorders, Autism spectrum disorders, DSM-5
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 14 Sep 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 verify the efficacy of NPC-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.
Detailed description
This study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. The trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. The screening phase comprises a screening visit where subject's initial eligibility will be evaluated. During double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned NPC-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPC-15 Granules Lower Dose | Experimental | Drug: NPC-15 Granules Lower DoseNPC-15 Granules Lower Dose group which is administered 1mg melatonin |
| NPC-15 Granules Higher Dose | Experimental | Drug: NPC-15 Granules Higher DoseNPC-15 Granules Higher Dose group which is administered 4 mg melatonin |
| NPC-15 Placebo Granule | Placebo comparator | Drug: NPC-15 Placebo GranuleNPC-15 Placebo Granules group which is administered placebo melatonin |
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 "autism spectrum 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 "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-15 Granules Lower DoseAlso: Melatonin 1mgNPC-15 granule which contains 1mg melatonin | Drug | NPC-15 Granules Lower Dose |
| NPC-15 Granules Higher DoseAlso: Melatonin 4mgMelatonin granule which contains 4 mg melatonin | Drug | NPC-15 Granules Higher Dose |
| NPC-15 Placebo GranuleAlso: PlaceboMelatonin placebo granule which does not contains melatonin. | Drug | NPC-15 Placebo Granule |
Primary outcome
Sleep latency with electronic sleep diary
Time frame: Week 2
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.
4 secondary outcomes
Sleep latency measured by actigraphy
Time frame: Week 2
Abnormal behavior checklist Japanese version
Time frame: Week 2, 9
Adverse events
Time frame: 10 weeks
Electro cardiogram
Time frame: 10 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.
- Derived from this study: PubMed 32912180Yuge K, Nagamitsu S, Ishikawa Y, Hamada I, Takahashi H, Sugioka H, Yotsuya O, Mishima K, Hayashi M, Yamashita Y. Long-term melatonin treatment for the sleep problems and aberrant behaviors of children with neurodevelopmental disorders. BMC Psychiatry. 2020 Sep 10;20(1):445. doi: 10.1186/s12888-020-02847-y.
- 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 2/3 study testing NPC-15 Granules Lower Dose and NPC-15 Granules Higher Dose in people with Sleep Disorders and Autism Spectrum 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (time frame: Week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02757066, which also lists 1 linked publication.
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.