Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities
Condition: Epilepsy; Insomnia; Developmental Disability
MeSH terms: Epilepsy; Sleep Initiation and Maintenance Disorders; Developmental Disabilities
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of oral melatonin in
      improving sleep continuity in children with epilepsy and neurodevelopmental delay who have
      chronic insomnia by comparing Fast Release Melatonin (FR MLT) to placebo and Timed Release
      Melatonin (TR MLT) with placebo in a randomized cross-over design trial.
    

Detailed description: 
      Sleep disturbance in children is a universal concern. The prevalence of sleep disorders may
      be as high as 80% in children with neurodevelopmental disabilities. The majority of the
      parental complaints are with difficulty getting children to settle to sleep at night and stay
      asleep (insomnia).

      Two recent studies comparing children with epilepsy to matched controls or to sibling
      controls both concluded that children with epilepsy have more daytime sleepiness that may be
      due to underlying sleep disorders, and significantly greater sleep problems than their
      non-epileptic peers.

      Endogenous melatonin is thought to synchronize the sleep-wake pattern with the light-dark
      cycle of the normal day. Exogenous melatonin has been found to be effective in reducing sleep
      onset latency, increasing sleep duration, and increasing sleep efficiency in a meta-analysis
      of subjects with sleep disorders. The melatonin in fast release preparations is released
      quickly and has a short half-life of less than 1 hour. It is most helpful in decreasing sleep
      onset latency (the time to fall asleep). The melatonin in timed release tablets is released
      in a slower more sustained way and, in a small study in children with severe
      neurodevelopmental disabilities, was more useful for sleep maintenance.

      Fast release melatonin has been shown to be effective in a study of children with multiple
      disabilities and in one trial in children with epilepsy. Further rigorous evaluation of
      melatonin is needed as the validity of these studies is limited by their lack of blinding,
      small sample sizes, and subjective methods of sleep-wake outcome evaluations.
    

Intervention name(s): Fast Release Melatonin (FR MLT); Fast Release Placebo; Timed Release Melatonin (TR MLT); Timed Release Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 3mg capsules of melatonin will be used. The dose of FR MLT will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.; A matching FR MLT placebo will be compounded by the SickKids research pharmacy.
The dose of Fast Release Placebo will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.; 3 mg capsules will be used.
The dose of TR MLT will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.; A matching TR MLT placebo will be compounded by the SickKids research pharmacy.
The dose of Timed Release Placebo will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
Other intervention name(s): Sleep Tight TM by Nature's Harmony® Melatonin; Melatonin Timed Release by General Nutrition Canada
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Pediatrics; Epilepsy; Insomnia; Melatonin