At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 147 enrolled
Drug / intervention
Melatonin +1 moredrug
Likely dose
Melatonin 2 mg daily for 4 weeksAI-extracted
Key inclusion· 3
- ✓Children aged 1–18 years
- ✓Confirmed diagnosis of epilepsy
- ✓Sleep problems
Key exclusion· 5
- ✕Bedridden with limited mobility
- ✕Liver or kidney dysfunction
- ✕Recent use of hypnotics, antidepressants, or anxiolytics within 4 weeks
- ✕Pregnant or breastfeeding (adolescent girls)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
In Brief
A Phase 3 clinical trial evaluating Melatonin and Placebo for Epilepsy in Children. Completed, enrolled 147 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy in Children
CountriesTaiwan
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartJul 2022
Primary CompletionJan 2025
TodayJul 2026
First PostedJun 30, 2022
Enrollment StartJul 18, 2022
Primary CompletionJan 3, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 4.0 years ago
Interventions
Melatonindrug
Melatonin 2 mg daily for 4 weeks
Placebodrug
Placebo daily for 4 weeks