Getting SMART for Pediatric Epilepsy
1 other identifier
interventional
147
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2025
CompletedResults Posted
Study results publicly available
August 29, 2025
CompletedAugust 29, 2025
August 1, 2025
2.5 years
June 20, 2022
June 2, 2025
August 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep Onset Latency
Sleep onset latency was assessed by actigraphy.
4 weeks
Secondary Outcomes (1)
Children's Sleep Disturbance
4 weeks
Study Arms (2)
Melatonin
EXPERIMENTALMelatonin
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- \- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 10051, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Shao-Yu Tsai
- Organization
- School of Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Wang-Tso Lee
National Taiwan University Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 30, 2022
Study Start
July 18, 2022
Primary Completion
January 3, 2025
Study Completion
January 3, 2025
Last Updated
August 29, 2025
Results First Posted
August 29, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share