Lennox-Gastaut SyndromePhase 4NCT01370486
Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
A Phase 4 study testing melatonin in people with Lennox-Gastaut Syndrome, run by Institution de Lavigny at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lennox-Gastaut Syndrome
- What is being tested?
- melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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...
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
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.
Read the 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.
- Conditions
- Lennox-Gastaut Syndrome
- Being tested
- melatonin, placebo
- Keywords
- Lennox-Gastaut syndrome, Epileptic encephalopathy, Melatonin, Tonic seizures, Interictal discharges, Quality of sleep
- Medical subject headings
- Lennox Gastaut Syndrome, Seizures, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDrug
Also called brand name: circadin
melatonin cp 2 mg 1x/d for 1 month
placeboDrug
placebo cp 1x/d for 1 month
| Study group | Role | What they receive |
|---|---|---|
| melatonin | Active comparator | Not described Receives: Drug: melatonin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: assessed after 1 month and 2.5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Why it stopped: The study did not received the approbation from Swissmedic. Therefore, the recruitment of participants never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lennox-Gastaut SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institution de Lavigny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni B. Foletti, MD, MER, Principal investigator, Institution de Lavigny
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370486
- Sponsor's protocol ID
- 25/10
- Status last verified
- Jul 2022
- First submitted
- 8 Jun 2011
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomised, Cross-over Study Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects
- ClinicalTrials.gov ID
- NCT01370486
- Acronym / sponsor ID
- 25/10
- Conditions
- Lennox-Gastaut Syndrome
- Keywords
- Lennox-Gastaut syndrome, Epileptic encephalopathy, Melatonin, Tonic seizures, Interictal discharges, Quality of sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not received the approbation from Swissmedic. Therefore, the recruitment of participants never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institution de LavignyUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin | Active comparator | Drug: melatonin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melatoninAlso: brand name: circadinmelatonin cp 2 mg 1x/d for 1 month | Drug | melatonin |
| placeboplacebo cp 1x/d for 1 month | Drug | placebo |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni B. Foletti, MD, MER principal investigator
Institution de Lavigny
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing melatonin in people with Lennox-Gastaut Syndrome, run by Institution de Lavigny at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.