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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
Sponsor:
Information provided by:

Study Description
Brief Summary:

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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370486


Contacts
Contact: Giovanni B. Foletti, MD, MER ++ 41 21 821 46 46 giovanni.foletti@ilavigny.ch

Locations
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.         
Sponsors and Collaborators
Institution de Lavigny
Investigators
Principal Investigator: Giovanni B. Foletti, MD, MER Institution de Lavigny
More Information

Responsible Party: M. Antonio Gallo, financial manager, Institution de Lavigny
ClinicalTrials.gov Identifier: NCT01370486     History of Changes
Other Study ID Numbers: 25/10
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Institution de Lavigny:
Lennox-Gastaut syndrome
Epileptic encephalopathy
Melatonin
Tonic seizures
Interictal discharges
Quality of sleep

Additional relevant MeSH terms:
Syndrome
Lennox Gastaut Syndrome
Disease
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants