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
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