Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects|
- 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 ] [ Designated as safety issue: No ]
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.
- 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. ] [ Designated as safety issue: No ]
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.
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: melatonin||
melatonin cp 2 mg 1x/d for 1 month
Other Name: brand name: circadin
|Placebo Comparator: placebo||
placebo cp 1x/d for 1 month
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370486
|Contact: Giovanni B. Foletti, MD, MER||++ 41 21 821 46 firstname.lastname@example.org|
|Institution de Lavigny||Not yet recruiting|
|Lavigny, Vaud, Switzerland, 1175|
|Contact: Giovanni B. Foletti, Dr, MD, MER ++ 41 21 821 46 46 email@example.com|
|Contact: Noëlle I. Mercier, Dr. ++ 41 21 821 41 11 firstname.lastname@example.org|
|Principal Investigator: Giovanni B. Foletti, Dr, MD, MER|
|Sub-Investigator: Sforza Emilia, Dr. , MD|
|Sub-Investigator: Noëlle Mercier, Dr.|
|Principal Investigator:||Giovanni B. Foletti, MD, MER||Institution de Lavigny|