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COMPLETEDPhase 2/3NCT05439876

Getting SMART for Pediatric Epilepsy

The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Lead sponsor: National Taiwan University Hospital•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

National Taiwan University Hospital

Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•\- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems

Exclusion Criteria

•Children who are bedridden with limited mobility
•Children with liver or kidney dysfunction
•Children on hypnotics, antidepressants, or anxiolytics within 4 weeks before the baseline clinic visit
•Adolescent girls who are pregnant or breastfeeding
•Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 29, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2/PHASE3

Enrollment147

Start dateJul 2022

Last updatedAug 29, 2025

Condition

Epilepsy in Children

Locations shown

National Taiwan University Hospital

Taipei

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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