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Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders (NPC-15-6)

Nobelpharma Co., Ltd. logo

Nobelpharma Co., Ltd.

Status and phase

Completed
Phase 3

Conditions

Sleep Disorders
Neurodevelopmental Disorder

Treatments

Drug: NPC-15

Study type

Interventional

Funder types

Industry

Identifiers

NCT02757079
NPC-15-6

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep diaries and the safety of NPC-15.

Full 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.

Enrollment

99 patients

Sex

All

Ages

6 to 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

99 participants in 1 patient group

NPC-15 Granule
Experimental group
Description:
NPC-15 granule 1 mg, 2 mg or 4 mg once a day, administered orally before going to bed.
Treatment:
Drug: NPC-15

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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