Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)