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

Overview

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.

Full Title of Study: “Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2012

Detailed Description

The aim of the trial is to study the efficacity of melatonin in the Lennox-Gastaut syndrome, by assessing the reduction of the seizure/interictal discharges in polysomnography and assessing the sleep structure. After initial recruitment, the baseline visit includes a polysomnography. The patients will then be randomised in two groups: melatonin (1 cp containing melatonin 2 mg 1x/d 1h before sleep) vs placebo (1 cp 1x/d 1h before sleep). The treatment (melatonin or placebo) will be given for 1 month. After 1 month, the treatment will be stopped and another polysomnography will be recorded. The patients will take no treatment (wash-out period) for 15 days. The second treatment phase is cross-over: the group that had melatonin in the first phase will take placebo for one month, and the group that had placebo in the first treatment phase will take melatonin for one month. A last polysomnography will be recorded after the second treatment phase. The other medications (antiepileptic drugs) taken by the patients before the trial will not be modified.

Interventions

  • Drug: melatonin
    • melatonin cp 2 mg 1x/d for 1 month
  • Drug: placebo
    • placebo cp 1x/d for 1 month

Arms, Groups and Cohorts

  • Active Comparator: melatonin
  • Placebo Comparator: placebo

Clinical Trial Outcome Measures

Primary Measures

  • diminution of at least 50% of the nocturnal interictal discharges and tonic seizures with the melatonin treatment
    • Time Frame: assessed after 1 month and 2.5 months
    • The patients will have three polysomnographic recording: at the baseline, one month after initiating the treatment (melatonin or placebo) and one month after the cross-over phase. The number of tonic seizure and if interictal discharges will be assessed. The primary outcome measure is a diminution of > 50% of the seizures/interictal discharges with the melatonin treatment.

Secondary Measures

  • augmentation of at least 15% of the amount of deep slow sleep with the melatonin treatment
    • Time Frame: assessed after 1 month and 2.5 months.
    • The structure of sleep will be measured with the polysomnography (at baseline, after 1 month and after 2.5 months. The outcome measure is an augmentation of at least 15% of the deep slow sleep.

Participating in This Clinical Trial

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…

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institution de Lavigny
  • Provider of Information About this Clinical Study
    • M. Antonio Gallo, financial manager, Institution de Lavigny
  • Overall Official(s)
    • Giovanni B. Foletti, MD, MER, Principal Investigator, Institution de Lavigny
  • Overall Contact(s)
    • Giovanni B. Foletti, MD, MER, ++ 41 21 821 46 46, giovanni.foletti@ilavigny.ch

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.