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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lennox-Gastaut Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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melatonin

Group Type ACTIVE_COMPARATOR

melatonin

Intervention Type DRUG

melatonin cp 2 mg 1x/d for 1 month

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo cp 1x/d for 1 month

Interventions

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melatonin

melatonin cp 2 mg 1x/d for 1 month

Intervention Type DRUG

placebo

placebo cp 1x/d for 1 month

Intervention Type DRUG

Other Intervention Names

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brand name: circadin

Eligibility Criteria

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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...

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No