Trial Outcomes & Findings for Getting SMART for Pediatric Epilepsy (NCT NCT05439876)
NCT ID: NCT05439876
Last Updated: 2025-08-29
Results Overview
Sleep onset latency was assessed by actigraphy.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
147 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-08-29
Participant Flow
Participant milestones
| Measure |
Melatonin, Then Placebo
Participants first received melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks. After a washout period of 2 weeks, they then received Placebo tablet each evening for 4 weeks.
|
Placebo, Then Melatonin
Participants first received Placebo tablet every night for 4 weeks. After a washout period of 2 weeks, they then received Melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks.
|
|---|---|---|
|
First Intervention (for 4 Weeks)
STARTED
|
73
|
74
|
|
First Intervention (for 4 Weeks)
COMPLETED
|
64
|
64
|
|
First Intervention (for 4 Weeks)
NOT COMPLETED
|
9
|
10
|
|
Wash-out Period (for 2 Weeks)
STARTED
|
64
|
64
|
|
Wash-out Period (for 2 Weeks)
COMPLETED
|
64
|
64
|
|
Wash-out Period (for 2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (for 4 Weeks)
STARTED
|
64
|
64
|
|
Second Intervention (for 4 Weeks)
COMPLETED
|
63
|
64
|
|
Second Intervention (for 4 Weeks)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Melatonin, Then Placebo
n=73 Participants
Melatonin First then Placebo
Participants first received melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks. After a washout period of 2 weeks, they then received Placebo tablet each evening for 4 weeks.
|
Placebo, Then Melatonin
n=74 Participants
Placebo First then Melatonin
Participants first received Placebo tablet every night for 4 weeks. After a washout period of 2 weeks, they then received Melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
73 Participants
n=73 Participants
|
74 Participants
n=74 Participants
|
147 Participants
n=147 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=73 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=147 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=73 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=147 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=73 Participants
|
34 Participants
n=74 Participants
|
68 Participants
n=147 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=73 Participants
|
40 Participants
n=74 Participants
|
79 Participants
n=147 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Taiwan
|
73 participants
n=73 Participants
|
74 participants
n=74 Participants
|
147 participants
n=147 Participants
|
|
Sleep Onset Latency
|
32.02 minutes
STANDARD_DEVIATION 22.06 • n=73 Participants
|
29.65 minutes
STANDARD_DEVIATION 21.75 • n=74 Participants
|
30.83 minutes
STANDARD_DEVIATION 21.84 • n=147 Participants
|
PRIMARY outcome
Timeframe: 4 weeksSleep onset latency was assessed by actigraphy.
Outcome measures
| Measure |
Melatonin
n=137 Participants
Melatonin
Melatonin: Melatonin 2 mg daily for 4 weeks
|
Placebo
n=138 Participants
Placebo
Placebo: Placebo daily for 4 weeks
|
|---|---|---|
|
Sleep Onset Latency
|
22.80 minutes
Standard Deviation 16.21
|
29.99 minutes
Standard Deviation 29.74
|
SECONDARY outcome
Timeframe: 4 weeksChildren'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.
Outcome measures
| Measure |
Melatonin
n=137 Participants
Melatonin
Melatonin: Melatonin 2 mg daily for 4 weeks
|
Placebo
n=138 Participants
Placebo
Placebo: Placebo daily for 4 weeks
|
|---|---|---|
|
Children's Sleep Disturbance
|
48.21 score on a scale
Standard Deviation 6.71
|
49.41 score on a scale
Standard Deviation 7.76
|
Adverse Events
Melatonin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Melatonin
n=137 participants at risk
Melatonin
Melatonin: Melatonin 2 mg daily for 4 weeks
|
Placebo
n=138 participants at risk
Placebo
Placebo: Placebo daily for 4 weeks
|
|---|---|---|
|
Nervous system disorders
mild hand weakness
|
0.73%
1/137 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
0.00%
0/138 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.73%
1/137 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
0.00%
0/138 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
|
Nervous system disorders
somnolence and fatigue
|
1.5%
2/137 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
0.00%
0/138 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
|
Nervous system disorders
increased seizure frequency
|
0.00%
0/137 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
0.72%
1/138 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
|
Nervous system disorders
body tremors
|
0.00%
0/137 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
0.72%
1/138 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
|
Nervous system disorders
agitation
|
0.00%
0/137 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
0.72%
1/138 • 14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
|
Additional Information
Shao-Yu Tsai
School of Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan
Phone: (02)23123456#288904
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place