Getting SMART for Pediatric Epilepsy

Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)

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

Study Overview

• Status: Completed
• Conditions: Epilepsy in Children
• Intervention / Treatment: Drug: Melatonin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10051
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo daily for 4 weeks; Other Names: Starch pill
Experimental: Melatonin	Drug: Melatonin; Melatonin 2 mg daily for 4 weeks; Other Names: Melatonin supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Onset Latency	Sleep onset latency was assessed by actigraphy.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Sleep Disturbance	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.	4 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wang-Tso Lee, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): January 3, 2025
• Study Completion (Actual): January 3, 2025

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Substandard Drugs; Pharmaceutical Preparations; Dietary Carbohydrates; Carbohydrates; Indoles; Polymers; Macromolecular Substances; Polysaccharides; Glucans; Tryptamines; Biopolymers; Melatonin; Counterfeit Drugs; Starch
• Other Study ID Numbers: 202012143MIPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No