Status:
COMPLETED
Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Epilepsy
Insomnia
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief 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 comp...
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 ...
Eligibility Criteria
Inclusion
- Children aged 5-17 years
- 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
- Planned epilepsy surgery or change in AED's during treatment trial
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01161108
Start Date
July 1 2010
End Date
June 1 2012
Last Update
December 2 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8