CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Melatonin +1 moredrug
Likely dose
Melatonin 9mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00965575
NCT00965575Phase 2Completed

Melatonin and Sleep in Patients With Epilepsy

Children's Hospital Medical Center, Cincinnati·interventional·Posted Aug 25, 2009·Updated Oct 1, 2020

In Brief

A Phase 2 clinical trial evaluating Melatonin and Placebos for Epilepsy. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The prevalence of epilepsy is 1% in the USA. About 30% of epilepsy patients eventually become refractory to medical treatment. Co morbid conditions are becoming as important as seizure control as these affect overall wellbeing. Sleep related complaints are frequent in them including, frequent arousals, difficulty falling asleep and excessive daytime sleepiness. Polysomnography shows increased arousal index, sleep onset latency, and stage shifts and fragmented REM sleep. Poor sleep efficiency causes daytime fatigue, poor cognition and behavior and can worsen seizure control. Stabilizing sleep may improve seizure control. Melatonin is a naturally occurring hormone in the body involved in the regulation of circadian rhythm and exogenously given, has been shown to decrease sleep onset latency, arousals, and there-by increase sleep efficiency in healthy pediatric patients. Similar data does not exist in the patients with epilepsy. As sleep has important impact on epilepsy and overall functioning, it is important to study effect of melatonin in children with epilepsy. We propose a randomized double blind placebo controlled trial with a cross-over design. Our hypothesis is that, for patients with epilepsy, administration of melatonin 30 minutes before bedtime for four weeks may: * Improve the quality of sleep; * Improve daytime functioning in terms of cognition, behavior and quality of life; * Decrease epileptic potential. We will use polysomnography, electroencephalogram, psychomotor vigilance task, seizure diary, and questionnaires to assess the effect of melatonin on these domains. This study may help to improve the care of children with epilepsy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2009
Enrollment StartJun 1, 2011
Primary CompletionJun 1, 2014
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.9 years ago

Interventions

Melatonindrug

Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Taken 30 minutes prior to bedtime for four weeks.

Placebosdrug

Placebo. Taken 30 minutes prior to bedtime for four weeks.