Status:
COMPLETED
Getting SMART for Pediatric Epilepsy
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Epilepsy in Children
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
PHASE3
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 pr...
Eligibility Criteria
Inclusion
- \- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
Exclusion
- 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
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2025
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT05439876
Start Date
July 18 2022
End Date
January 3 2025
Last Update
August 29 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 10051