Back to resultsGetting SMART for Pediatric Epilepsy
Primary Purpose
Epilepsy in Children
Status
Recruiting
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy in Children
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 medication for sleep or mood problems 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
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Melatonin
Placebo
Arm Description
Melatonin
Placebo
Outcomes
Primary Outcome Measures
Sleep quality
Sleep quality as assessed by actigraphy
Secondary Outcome Measures
Behavioral profile
T scores as assessed by Child Behavior Checklist. A T score has a mean of 50 and standard deviation of 10, with higher scores representing more behavioral problems.
Full Information
NCT ID
NCT05439876
First Posted
June 20, 2022
Last Updated
September 15, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05439876
Brief Title
Getting SMART for Pediatric Epilepsy
Official Title
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Melatonin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Melatonin
Other Intervention Name(s)
Melatonin supplement
Intervention Description
Melatonin 2 mg daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Starch pill
Intervention Description
Placebo daily for 4 weeks
Primary Outcome Measure Information:
Title
Sleep quality
Description
Sleep quality as assessed by actigraphy
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Behavioral profile
Description
T scores as assessed by Child Behavior Checklist. A T score has a mean of 50 and standard deviation of 10, with higher scores representing more behavioral problems.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 medication for sleep or mood problems 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Yu Tsai
Phone
2312-3456
Ext
88904
Email
stsai@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Lai
Phone
2312-3456
Ext
88904
Email
sabrina0530s@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang-Tso Lee
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shao-Yu Tsai
Email
stsai@ntu.edu.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Getting SMART for Pediatric Epilepsy
We'll reach out to this number within 24 hrs