Phase 3
N=147
Getting SMART for Pediatric Epilepsy
Epilepsy in Children
Bottom Line
View on ClinicalTrials.gov: NCT05439876 ↗Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Sleep Onset Latency — 22.80; 29.99 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Melatonin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- National Taiwan University Hospital
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Onset Latency |
22.80; 29.99 | — |
| SECONDARY Children's Sleep Disturbance |
48.21; 49.41 | — |
Summary
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05439876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.