Phase 3
Completed N=147
Getting SMART for Pediatric Epilepsy
Epilepsy in Children
Source: ClinicalTrials.gov NCT05439876 ↗
Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Sleep Onset Latency — 22.80; 29.99 minutes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Onset Latency |
22.80; 29.99 | — |
| SECONDARY Children's Sleep Disturbance |
48.21; 49.41 | — |
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. Informational only — not medical advice.