Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lennox-Gastaut Syndrome |
Drug: melatonin Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 6 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: melatonin |
Drug: melatonin
melatonin cp 2 mg 1x/d for 1 month
Other Name: brand name: circadin
|
| Placebo Comparator: placebo |
Drug: placebo
placebo cp 1x/d for 1 month
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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...
Contacts and Locations| Contact: Giovanni B. Foletti, MD, MER | ++ 41 21 821 46 46 | giovanni.foletti@ilavigny.ch |
| Switzerland | |
| Institution de Lavigny | Not yet recruiting |
| Lavigny, Vaud, Switzerland, 1175 | |
| Contact: Giovanni B. Foletti, Dr, MD, MER ++ 41 21 821 46 46 giovanni.foletti@ilavigny.ch | |
| Contact: Noëlle I. Mercier, Dr. ++ 41 21 821 41 11 noelle.mercier@ilavigny.ch | |
| 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 |
More Information
No publications provided
| Responsible Party: | M. Antonio Gallo, financial manager, Institution de Lavigny |
| ClinicalTrials.gov Identifier: | NCT01370486 History of Changes |
| Other Study ID Numbers: | 25/10 |
| Study First Received: | June 8, 2011 |
| Last Updated: | June 9, 2011 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Institution de Lavigny:
|
Lennox-Gastaut syndrome Epileptic encephalopathy Melatonin |
Tonic seizures Interictal discharges Quality of sleep |
Additional relevant MeSH terms:
|
Mental Retardation Spasms, Infantile Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Mental Disorders Diagnosed in Childhood Mental Disorders Epilepsy, Generalized Epilepsy Brain Diseases |
Central Nervous System Diseases Melatonin Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013