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

• Status: Unknown status
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institution de Lavigny
• Treatments: Melatonin

Criteria

Inclusion Criteria:

• Lennox-Gastaut syndrome (based on ILAE classification, 1989)

• light mental retardation (QI 50-69)

• french mother tongue

• having someone helping the patient (parent and/or referent educator)

• informed consent have been given by the patient / guardian

• absence of concomitant evolutive affection or associated sleep pathologies

• collaboration of the patient, ability to complete all aspects of the trial.

Exclusion Criteria:

• epileptic syndrome other than Lennox-Gastaut, other neurologic and/or psychiatric disease

• moderate to severe mental retardation (QI < 50)

• psychiatric disease that could interfere with the diagnostic procedure

• specific sleep disorder (anamnestic and diagnosed on the polygraphic record), for example: sleep apnea syndrome, narcolepsy, restless legs syndrome, periodic legs movements, etc...