drugset / Trial / NCT01161108
Trial of Melatonin to Improve Sleep in Children With Epilepsy and Neurodevelopmental Disabilities
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 3 mg | Oral |
| Comparator | Melatonin | Small molecule | 6 mg | Oral |