Pilot Study of Melatonin and Epilepsy

Completed · Phase 2 · Has a placebo group

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00965575

Run by

Children's Hospital Medical Center, Cincinnati

People needed

11

Starts

2011-06-01

Expected to finish

2014-08-01

Last updated by the study team

2020-10-01

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6-11 years (prepubertal based on tanner staging)
• Patients with epilepsy (diagnosis based on ILAE).
• Normal intelligence based on school placement (defined as age appropriate; an IEP due to epilepsy related causes is acceptable as is placement in a higher grade) or IQ>70 (testing done with in 12 months of enrollment)
• No history of significant snoring- loud snoring every night outside of a room with closed door
• Combined score of 30 or more on sleep fragmentation, parasomnia and daytime drowsiness subscales on SBQ.

You may not qualify if…

• History of significant snoring- loud snoring every night heard outside of a room with closed door
• Diagnosis of obstructive sleep apnea (OSA) or periodic limb movement disorder on PSG
• Vagus nerve stimulator implanted
• History of a major psychiatric disease (e.g. psychosis, major depression)
• History of autism or pervasive development disorder
• Severe neuro-developmental disabilities, as determined by PI
• Clinically significant systemic organic disease, as determined by PI
• Current use of melatonin or sustained release melatonin
• Prior use of sustained release melatonin
• Current use of any hypnotic medications except for medications used as a rescue treatment for seizures
• Use of psychoactive or stimulant medication for attention deficit disorders
• Subjects with immune disorders, lympho-proliferative disorders, and those taking oral corticosteroids or other immuno-suppressants
• Subject or parent/legal guardian might not be reasonably expected to be compliant with or to complete the study.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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