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

NCT01370486 | Withdrawn Phase 4

• 1 other identifier: 25/10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lennox-Gastaut Syndrome

Keywords

Lennox-Gastaut syndrome; Epileptic encephalopathy; Melatonin; Tonic seizures; Interictal discharges; Quality of sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• augmentation of at least 15% of the amount of deep slow sleep with the melatonin treatment

  assessed after 1 month and 2.5 months.

Study Arms (2)

melatonin

ACTIVE COMPARATOR

Drug: melatonin

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

melatonin DRUG

melatonin cp 2 mg 1x/d for 1 month

Also known as: brand name: circadin

melatonin

placebo DRUG

placebo cp 1x/d for 1 month

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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...

Sponsors & Collaborators

• Institution de Lavigny: lead

Study Sites (1)

Institution de Lavigny

Lavigny, Canton of Vaud, 1175, Switzerland

Location

MeSH Terms

Conditions

Lennox Gastaut Syndrome; Seizures; Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Epileptic Syndromes; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Giovanni B. Foletti, MD, MER

  Institution de Lavigny

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 10, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

CH (1)