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Pilot Study of Melatonin and Refractory Epilepsy

This study is currently recruiting participants.
Verified August 2012 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00965575
First received: August 24, 2009
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Epilepsy
 Drug: Melatonin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin and Sleep in Patients With Refractory Epilepsy

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Increased sleep efficiency on polysomnography (PSG)and improved lapse time on psychomotor vigilance task (PVT) [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of epileptiform discharges on EEG and seizure frequency [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: June 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melatonin
Subjects will take sustained release melatonin 30 minutes prior to bedtime for four weeks
 Drug: Melatonin
Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.
Placebo Comparator: Placebo
Subjects will take a placebo 30 minutes before bedtime for four weeks
 Drug: Melatonin
Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965575

Contacts
Contact: Sejal Jain, M.D. 513-636-8681 sejal.jain@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Sejal Jain, M.D.     513-636-8681     sejal.jain@cchmc.org    
Principal Investigator: Sejal Jain, M.D.            
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00965575     History of Changes
Other Study ID Numbers: 2009-1042
Study First Received: August 24, 2009
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
epilepsy
sleep
seizures
cognition

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Melatonin
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013