Epilepsy in ChildrenPhase 2/3NCT05439876
Getting SMART for Pediatric Epilepsy
A Phase 2/3 study testing Melatonin in people with Epilepsy in Children, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jul 2022to 3 Jan 2025
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Read the detailed description
Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
- Conditions
- Epilepsy in Children
- Being tested
- Melatonin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Melatonin supplement
Melatonin 2 mg daily for 4 weeks
PlaceboDrug
Also called Starch pill
Placebo daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Melatonin Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency
Sleep onset latency was assessed by actigraphy.
Measured: 4 weeks
Secondary outcomes (1)
Children's Sleep Disturbance
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start18 Jul 2022
- Primary completion3 Jan 2025
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang-Tso Lee, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439876
- Sponsor's protocol ID
- 202012143MIPC
- Status last verified
- Aug 2025
- First submitted
- 20 Jun 2022
- Last updated
- 9 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
- ClinicalTrials.gov ID
- NCT05439876
- Acronym / sponsor ID
- 202012143MIPC
- Conditions
- Epilepsy in Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Detailed description
Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninMelatonin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: Melatonin supplementMelatonin 2 mg daily for 4 weeks | Drug | Melatonin |
| PlaceboAlso: Starch pillPlacebo daily for 4 weeks | Drug | Placebo |
Primary outcome
Sleep Onset Latency
Time frame: 4 weeks
Sleep onset latency was assessed by actigraphy.
1 secondary outcome
Children's Sleep Disturbance
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Epilepsy in Children
Active, not recruitingPhase 3
A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
Dravet Syndrome
RecruitingObservational study
Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
Perinatal Stroke, Epilepsy
RecruitingPhase 1/2
A Clinical Study to Evaluate the Safety and Efficacy of ETX101 in Infants and Children With SCN1A-Positive Dravet Syndrome
Dravet Syndrome
Not yet recruitingObservational study
Antiseizure Medications and CBC in Children With Epilepsy
Epilepsy
Recruiting
Sleep, Music, And Research Trial 2.0
Epilepsy in Children, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang-Tso Lee principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melatonin in people with Epilepsy in Children, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Onset Latency (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.