Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities
NCT ID: NCT01161108
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
13 participants
INTERVENTIONAL
2010-07-31
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Group A: Fast Release Melatonin
Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa).
Fast Release Melatonin (FR MLT)
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.
Fast Release Placebo
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.
Group B: Timed Release Melatonin
Subjects will be randomized to one of the two treatment arms and to the order of study medication v.s. placebo.
The subject will undergo the assigned treatment for 7 weeks (3 weeks of study drug, a one week wash-out and 3 weeks of placebo, or vice versa).
Timed Release Melatonin (TR MLT)
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.
Timed Release Placebo
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.
Interventions
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Fast Release Melatonin (FR MLT)
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.
Fast Release Placebo
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.
Timed Release Melatonin (TR MLT)
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.
Timed Release Placebo
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 Names
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Eligibility Criteria
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Inclusion Criteria
* Children with epilepsy with at least 2 partial or generalized seizures per month over the last 3 months prior to starting the trial
* Children with neurodevelopmental disability, i.e. significant delay in development requiring special educational setting or educational assistant
* Anti-epileptic drugs (AED's) expected to remain unchanged for duration of trial (14 weeks)
* Not currently using melatonin or any other medication for sleep Subjects will be eligible if they have previous use of melatonin as long as there is a washout period of at least 1 week. Similarly, children taking natural health products for sleep will be included as long as there is a 30 day washout period prior to study enrollment.
* Chronic insomnia - reported by parent(s) to include one of the following: sleep onset latency of greater than one hour, duration of sleep less than 8.5 hours per night with either/or both these problems occurring at least 3 nights per week and that have occurred 3 months prior to trial, or night wakings of more than 2 per night for same time period
Exclusion Criteria
* Sleep disturbances that are treatable such as obstructive sleep apnea
* Allergy or severe adverse effects to melatonin
* Allergy or severe adverse effects to any of the ingredients of the study product or placebo (e.g. lactose)
* Lactose intolerance
* Pregnant
* Breastfeeding
* Known liver disease
* Ketogenic diet
* Other drugs being used for sedation
* Immunosuppressive drugs
* Known blood clotting abnormalities or who are on anticoagulant therapy (e.g. warfarin, blood thinners)
5 Years
17 Years
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Shelly Weiss
Staff neurologist
Principal Investigators
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Shelly Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Other Identifiers
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1000010842
Identifier Type: -
Identifier Source: org_study_id