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

PHASE3CompletedINTERVENTIONAL
Enrollment

99

Participants

Timeline

Start Date

June 21, 2016

Primary Completion Date

July 31, 2018

Study Completion Date

July 6, 2018

Conditions
Sleep DisordersNeurodevelopmental Disorder
Interventions
DRUG

NPC-15

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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nobelpharma

INDUSTRY

NCT02757079 - Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders | Biotech Hunter | Biotech Hunter