Trial · NCT05439876

Getting SMART for Pediatric Epilepsy

NCT05439876, Phase 2, Phase 3, Completed, National Taiwan University Hospital; results first posted 2025-08-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Getting SMART for Pediatric Epilepsy. Trials, record NCT05439876. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05439876

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Getting SMART for Pediatric Epilepsy
NCT number: NCT05439876
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 147 participants, actual
Lead sponsor: National Taiwan University Hospital
Conditions: Epilepsy in Children
Interventions: Melatonin, Placebo
First posted: 2022-06-30
Last updated: 2026-10-09
Results first posted: 2025-08-29

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Sleep Onset Latency	4 weeks	Sleep onset latency was assessed by actigraphy.
Secondary	Children's Sleep Disturbance	4 weeks	Children's sleep disturbance was assessed by Children's Sleep Habits Questionnaire (CSHQ) total sleep disturbance score. There are 33 questions sumed as total score, range between 33 to 99. Higher score indicated more sleep disturbance problems in children.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Sleep Onset Latency	4 weeks		minutes	MEAN
SECONDARY	Children's Sleep Disturbance	4 weeks		score on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Sleep Onset Latency	Melatonin	22.80	Standard Deviation 16.21	minutes
Sleep Onset Latency	Placebo	29.99	Standard Deviation 29.74	minutes
Children's Sleep Disturbance	Melatonin	48.21	Standard Deviation 6.71	score on a scale
Children's Sleep Disturbance	Placebo	49.41	Standard Deviation 7.76	score on a scale

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (for 4 Weeks)	STARTED	Melatonin, Then Placebo	73
First Intervention (for 4 Weeks)	STARTED	Placebo, Then Melatonin	74
First Intervention (for 4 Weeks)	COMPLETED	Melatonin, Then Placebo	64
First Intervention (for 4 Weeks)	COMPLETED	Placebo, Then Melatonin	64
First Intervention (for 4 Weeks)	NOT COMPLETED	Melatonin, Then Placebo	9
First Intervention (for 4 Weeks)	NOT COMPLETED	Placebo, Then Melatonin	10
Wash-out Period (for 2 Weeks)	STARTED	Melatonin, Then Placebo	64
Wash-out Period (for 2 Weeks)	STARTED	Placebo, Then Melatonin	64
Wash-out Period (for 2 Weeks)	COMPLETED	Melatonin, Then Placebo	64
Wash-out Period (for 2 Weeks)	COMPLETED	Placebo, Then Melatonin	64

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	mild hand weakness	Nervous system disorders	Melatonin	1	137
other	mild hand weakness	Nervous system disorders	Placebo	0	138
other	decreased appetite	Metabolism and nutrition disorders	Melatonin	1	137
other	decreased appetite	Metabolism and nutrition disorders	Placebo	0	138
other	somnolence and fatigue	Nervous system disorders	Melatonin	2	137
other	somnolence and fatigue	Nervous system disorders	Placebo	0	138
other	increased seizure frequency	Nervous system disorders	Melatonin	0	137
other	increased seizure frequency	Nervous system disorders	Placebo	1	138
other	body tremors	Nervous system disorders	Melatonin	0	137
other	body tremors	Nervous system disorders	Placebo	1	138

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melatonin	0	137
Total, all-cause mortality	Placebo	0	138
Total, other adverse events	Melatonin	3	137
Total, other adverse events	Placebo	3	138
Total, serious adverse events	Melatonin	0	137
Total, serious adverse events	Placebo	0	138

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Melatonin vs Placebo: deaths from any cause	Trial comparisons
Melatonin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05439876

GET https://conductscience.org/api/trials/v1/NCT05439876/registered

API reference For AI assistants