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Verification of the Efficacy of NPC-15 for Sleep Disorders of Children With Autism Spectrum Disorders (NPC-15-5)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02757066
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Disorders Autism Spectrum Disorder Drug: NPC-15 Granules Lower Dose Drug: NPC-15 Granules Higher Dose Drug: NPC-15 Placebo Granule Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II/III Clinical Trial of NPC-15 - Verification of the Efficacy for Sleep Disorders of Children With Autism Spectrum Disorders -
Actual Study Start Date : June 16, 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 14, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: NPC-15 Granules Lower Dose
NPC-15 Granules Lower Dose group which is administered 1mg melatonin
Drug: NPC-15 Granules Lower Dose
NPC-15 granule which contains 1mg melatonin
Other Name: Melatonin 1mg

Experimental: NPC-15 Granules Higher Dose
NPC-15 Granules Higher Dose group which is administered 4 mg melatonin
Drug: NPC-15 Granules Higher Dose
Melatonin granule which contains 4 mg melatonin
Other Name: Melatonin 4mg

Placebo Comparator: NPC-15 Placebo Granule
NPC-15 Placebo Granules group which is administered placebo melatonin
Drug: NPC-15 Placebo Granule
Melatonin placebo granule which does not contains melatonin.
Other Name: Placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Sleep latency measured by actigraphy [ Time Frame: Week 2 ]
    To assess the efficacy of this drug in detail

  2. Abnormal behavior checklist Japanese version [ Time Frame: Week 2, 9 ]
    To assess effects of this drug on neurodevelopment disorders

  3. Adverse events [ Time Frame: 10 weeks ]
    To assess safety of this drug

  4. Electro cardiogram [ Time Frame: 10 weeks ]
    To assess safety of this drug



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757066


Sponsors and Collaborators
Nobelpharma
Investigators
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Principal Investigator: Yushiro Yamashita, MD, PhD The Department of Pediatrics and Child Health Kurume University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT02757066    
Other Study ID Numbers: NPC-15-5
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nobelpharma:
Melatonin
NPC-15
Sleep disorders
Autism spectrum disorders
DSM-5
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants