drugset / Trial / NCT01161108

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

NCT01161108

Phase 3 Completed 13 enrolled The Hospital for Sick Children
RandomizedCrossoverSingle-blindTreatment

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.

Timeline

Start
2010-07
Primary completion
2012-05
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 3 mg Oral
Comparator Melatonin Small molecule 6 mg Oral