Getting SMART for Pediatric Epilepsy

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National Taiwan University

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Epilepsy in Children

Treatments

Drug: Placebo
Drug: Melatonin

Study type

Interventional

Funder types

Other

Identifiers

NCT05439876
202012143MIPC

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

120 participants in 2 patient groups, including a placebo group

Melatonin
Experimental group
Description:
Melatonin
Treatment:
Drug: Melatonin
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Sabrina Lai; Shao-Yu Tsai

Data sourced from clinicaltrials.gov

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