Pilot Study of Melatonin and Epilepsy

NCT00965575 | Completed Phase 2 Results DMC

• 1 other identifier: 2009-1042
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Keywords

epilepsy; sleep; seizures; cognition

Outcome Measures

Primary Outcomes (1)

• Sleep Latency Wakefulness After Sleep Onset (WASO)

  Sleep Latency Wakefulness After Sleep Onset (WASO). Calculated as the sum of wake time minutes from sleep onset to the final awakening.

  13 weeks

Secondary Outcomes (1)

• Seizure Frequency

  13 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks

Drug: Melatonin

Placebos

PLACEBO COMPARATOR

Subjects will take a placebo 30 minutes before bedtime for four weeks

Drug: Placebos

Interventions

Melatonin DRUG

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

Also known as: natural supplement

Melatonin

Placebos DRUG

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

Also known as: Placebo

Placebos

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Links

• Sleep Medicine

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Sejal Jain
• Organization: Cincinnti Childrens

sejal.jain@cchmc.org

513-636-4222

Study Officials

• Sejal Jain, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: June 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)