Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
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|ClinicalTrials.gov Identifier: NCT01370486|
Recruitment Status : Unknown
Verified June 2011 by Institution de Lavigny.
Recruitment status was: Not yet recruiting
First Posted : June 10, 2011
Last Update Posted : June 10, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lennox-Gastaut Syndrome||Drug: melatonin Drug: placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2012|
U.S. FDA Resources
|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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|