drugset / Trial / NCT01370486

Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects

NCT01370486

Phase 4 Withdrawn Institution de Lavigny
RandomizedCrossoverQuadruple-blindTreatment

Summary

Lennox-Gastaut syndrome is a severe epileptic encephalopathy of childhood. In that syndrome, various type of seizure occur, mainly tonic seizures, atonic seizures and atypical absences. The tonic seizure occur mostly at night. The hypothesis is that the melatonin could have a positive effect in that syndrome, by reducing the epileptic activity (assessed in the polysomnographic record by counting the number of interictal and ictal discharges) and stabilizing the structure of sleep. The study is double blind, randomised, cross-over designed.

Timeline

Start
2011-08
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Melatonin Small molecule 2 mg