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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01370486
Date of registration: 08/06/2011
Prospective Registration: Yes
Primary sponsor: Institution de Lavigny
Public title: Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
Scientific title: Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
Date of first enrolment: August 2011
Target sample size: 6
Recruitment status: Not yet recruiting
URL:  http://clinicaltrials.gov/show/NCT01370486
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  
Phase:  Phase 4
Countries of recruitment
Switzerland
Contacts
Name:     Giovanni B. Foletti, Dr, MD, MER
Address: 
Telephone: ++ 41 21 821 46 46
Email: giovanni.foletti@ilavigny.ch
Affiliation: 
Name:     Giovanni B. Foletti, MD, MER
Address: 
Telephone: ++ 41 21 821 46 46
Email: giovanni.foletti@ilavigny.ch
Affiliation: 
Name:     Giovanni B. Foletti, MD, MER
Address: 
Telephone:
Email:
Affiliation:  Institution de Lavigny
Key inclusion & exclusion 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...



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Lennox-Gastaut Syndrome
Intervention(s)
Drug: melatonin
Drug: placebo
Primary Outcome(s)
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]
Secondary Outcome(s)
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.]
Secondary ID(s)
25/10
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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