Status:
COMPLETED
Pilot Study of Melatonin and Epilepsy
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Epilepsy
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
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 thes...
Detailed Description
Hypothesis 1: Melatonin treatment improves the quality of sleep in patients with epilepsy. Various studies evaluating sleep problems in patients with epilepsy using questionnaires have shown that 34-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00965575
Start Date
June 1 2011
End Date
August 1 2014
Last Update
October 1 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229