Getting SMART for Pediatric Epilepsy

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

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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