Getting SMART for Pediatric Epilepsy

Phase 2

Completed

• Conditions: Epilepsy in Children
• Interventions: Drug: Placebo; Drug: Melatonin

• Registration Number: NCT05439876
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-26
• Study First Posted: 2022-06-30
• Study Start: 2022-07-18
• Primary Completion: 2025-01-03
• Study Completion: 2025-01-03
• Results First Submitted: 2025-06-02
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Results First Posted: 2025-08-29
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Melatonin	Melatonin	Melatonin

Primary Outcome Measures

Name	Time	Method
Sleep Onset Latency	4 weeks	Sleep onset latency was assessed by actigraphy.

Secondary Outcome Measures

Name	Time	Method
Children's Sleep Disturbance	4 weeks	Children's sleep disturbance was assessed by Children's Sleep Habits Questionnaire (CSHQ) total sleep disturbance score. There are 33 questions sumed as total score, range between 33 to 99. Higher score indicated more sleep disturbance problems in children.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan