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

Lennox-Gastaut Syndrome Clinical Trial

Official title:

Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01370486
• Other study ID #: 25/10
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2022
• Source: Institution de Lavigny
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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...

Related Conditions & MeSH terms

• Lennox Gastaut Syndrome
• Lennox-Gastaut Syndrome
• Syndrome

Intervention

Drug:
• melatonin
melatonin cp 2 mg 1x/d for 1 month
• placebo
placebo cp 1x/d for 1 month

Locations

Country	Name	City	State
Switzerland	Institution de Lavigny	Lavigny	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Institution de Lavigny

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diminution of at least 50% of the nocturnal interictal discharges and tonic seizures with the melatonin treatment	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.	assessed after 1 month and 2.5 months
Secondary	augmentation of at least 15% of the amount of deep slow sleep with the melatonin treatment	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.	assessed after 1 month and 2.5 months.