Electrical Status Epilepticus in SleepESES-ClobazamNCT02127918
Electrical Status Epilepticus in Sleep: Response of Neuropsychological Deficits and Epileptiform Activity to Clobazam Treatment
An observational study of Electrical Status Epilepticus in Sleep, run by Boston Children's Hospital at 2 sites in United States.
Trial summary
Electrical status epilepticus in sleep (ESES) is a pattern of abnormal discharges in the electroencephalogram (EEG). Children who have this pattern present seizures and neuropsychological regression. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Electrical Status Epilepticus in Sleep
- What is being tested?
- ESES treated with clobazam
- Type of treatment
- Pill or oral medicine
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Jul 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Investigators will enroll patients with ESES studied at our centers and treated with high-dose clobazam treatment as decided by the clinical epileptologist. Patients with ESES are monitored once or twice a year in the long-term electroencephalogram monitoring unit to assess epileptiform activity. Patients with very active discharges and neuropsychological regression require a change in their treatment regimen. If the treating epileptologist decides that high-dose cloblazam treatment is indicated for clinical reasons, then the patient will be offered to participate in the study. The research team will not be responsible for or influence the treatment decisions in any way.
Who may be able to join
- A change in treatment regimen is required because of very active epileptiform activity during sleep and neuropsychological regression. This means that only patients with very active epileptiform activity and, therefore, with a need for a change in treatment regimen as clinically indicated will be potentially eligible. Additionally, a prior clinical decision to use clobazam should have been made by the primary epileptologist in order to participate in the study.
- Availability for clinical, neuropsychological and EEG follow-up.
Who cannot join
- Electro-clinical evolution that does not require a change in medication regimen or changes in medication regimen that do not include clobazam.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Electrical status epilepticus in sleep (ESES) is a pattern of abnormal discharges in the electroencephalogram (EEG). Children who have this pattern present seizures and neuropsychological regression. There are no studies that systematically evaluate the response of abnormal discharges in the EEG, seizures and neuropsychological regression to different antiepileptic treatments. Therefore, treatment strategies in ESES are not based on scientific evidence. High-dose benzodiazepines such as diazepam (valium) have been reported to improve the severe EEG abnormalities of patients with ESES in the short-term. But the long-term response of seizures and neuropsychological regression has not been systematically studied. Clobazam is a benzodiazepine derivative with antiepileptic properties. The pharmacologic properties of clobazam make of this drug a particularly useful option in ESES: in patients with ESES the alpha-2 subunit of the GABA receptor is preferentially up-regulated and clobazam may have a higher affinity for this particular subunit, so investigators expect a higher effect of this drug on ESES patients than with other benzodiazepines (Loddenkemper et al, in preparation). The aim of our study is to objectively evaluate the response to clobazam treatment of neuropsychological deficits, seizures and abnormal discharges in the EEG in patients with ESES. Clobazam treatment is used in routine clinical practice and investigators will objectively quantify its effect.
Our working hypothesis is that high-dose clobazam treatment may control the abnormal epileptiform discharges in the EEG in patients with ESES. The reduction in abnormal epileptiform discharges may lead to an improvement in neuropsychological deficits and seizures. The predicted improvement in seizures and neuropsychological function would lead to a better quality of life in these patients.
Read the detailed description
- A. RESEARCH METHODS
Study design. Investigators will perform a prospective descriptive cohort study with historical controls.
Participating institutions. Children's Hospital Boston (PI: Tobias Loddenkemper) and Children's Hospital Colorado (PI: Kevin Chapman).
Patients. Investigators will enroll patients with ESES studied at our centers and treated with high-dose clobazam treatment as decided by the clinical epileptologist.
The diagnosis of ESES will be confirmed based on neuropsychological regression in at least one domain of development, the presence of seizures that appear in an age-related manner and the presence in the EEG of the ESES pattern (Loddenkemper, et al. 2011a).
Contact with the patients. Once that the potential candidate is recognized (patient with ESES, a change in medication regimen is decided that includes initiation of clobazam), the research team will contact the primary epileptologist. The primary epileptologist will contact the patient in order to check whether the family and/or patient would like to be contacted for this research protocol. If the patient agrees to be contacted, the research team will contact the patient in order to propose them to participate in the study.
EEG assessment. Investigators will assess the epileptiform activity in the long-term monitoring unit before and after treatment for every patient.Assessment of clinical data. The clinical charts of the patients included in the study will be collected reviewed for relevant clinical information. This information will be updated and complemented with the patient and/or the family during the admissions for long-term monitoring. Assessment of neuropsychological data: A battery of neuropsychological tests will be performed by board-certified clinical neuropsychologists to obtain information regarding cognitive abilities.
Safety measures. Investigators will continuously monitor patients for adverse effects during hospitalization and provide them with contact information for continuous report of possible adverse effects. Potential risk to subjects. As subjects will be using a FDA-approved drug for the treatment of epilepsy their risk will be the same as in routine clinical care. There will not be risks associated with the specific use of clobazam as it is routinely used for clinical care and the decision to use it or not will depend on the primary provider and not on the research team. Other potential risks are related with the loss of privacy and confidentiality. Investigators will develop mechanisms to ensure protection of patients' privacy and confidentiality.
Quality control method. Investigators will perform quality control measures every 5 collected patients at Children's Hospital Boston. Additionally, independent medical monitoring will be implemented.
- B. STATISTICAL ANALYSIS
Calculation of the sample size. Our previous study with diazepam treatment (Sánchez Fernández, et al. in press-a) found that the difference in epileptiform activity before and after treatment was of around 30%. There are no other data available on the quantification of the response of epileptiform activity to antiepileptic treatment.
- C. PLANS FOR MISSING DATA
Recruitment of patients. Patients with ESES frequently belong to the category of patients that are not able to understand the study protocol both because of their age and because of neuropsychological regression. Their families and/or caretakers will decide in most cases about study enrollment and the patient consent/assent will be looked for when developmentally possible. Although studies with patients with severe developmental delays pose significant challenges, the burden of participating in the study will not be significantly different from the burden of normal clinical care. Additionally this study will be performed at centers that are familiar with the care of patients with severe developmental delay.
Sample size. Power calculation for the proposed study is challenging due to the novel approach. Our preliminary data, however, strongly favor feasibility and completion.
- Conditions
- Electrical Status Epilepticus in Sleep
- Being tested
- ESES treated with clobazam
- Keywords
- Electrical status epilepticus in sleep, Continuous spikes and waves during sleep, Children, Electroencephalogram, Neuropsychology, Development, Antiepileptic drugs, Clobazam, Seizures
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESES treated with clobazamDrug
The patients that will participate in the protocol will be those that are administered for clinical reasons oral clobazam.
| Study group | Role | What they receive |
|---|---|---|
| ESES treated with clobazam | The patients that will participate in the protocol will be those that are administered for clinical reasons oral clobazam. Receives: Drug: ESES treated with clobazam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive ability
A neuropsycholgist will assess the patient's change in cognitive ability in response to treatment with clobazam using theDifferential Ability Scales- Second Edition.
Measured: Measured the day before and 3 months after starting treatment
Language
A neuropsychologist will assess the patient's change in language ability in response to clobazam using the Peabody Picture Vocabulary Test-Fourth Edition, Word Generation and NEPSY: A Developmental Neuropsychological Assessment-Second Edition.
Measured: Measured the day before and 3 months after starting treatment.
Executive function
A parent will fill out the Behavior Rating Inventory of Executive Function, and CogState, to assess the patient's change in executive function in response to clobazam.
Measured: Measured the day before and 3 months after starting clobazam
Adaptive/development skills
A parent will fill out the Scales of Independent Behaviors-Revised and The Developmental Profile-Third Edition to assess the patient's adaptive/developmental skills.
Measured: Measured the day before and three months after starting clobazam
Behavior
The parent will fill out the Child Behavior Checklist to assess the patient's behavior change in response to clobazam.
Measured: Measured the day before and three months after starting clobazam
Secondary outcomes (1)
Interictal epileptiform activity
We will assess the epileptiform activity in the long-term monitoring unit during three different points for every patient: immediately before the treatment, immediately after the treatment and three months after the treatment. We will assess epileptiform activity using the first five minutes of NREM2 sleep during the first non-REM sleep cycle in each night sleep. We will quantify epileptiform activity using two different methods: 1) the spike-wave percentage as the percentage of one-second bins with at least one spike-wave complex; and 2) the spike frequency as the average number of spike-wave complexes per 100 seconds.
Measured: The night before the patient starts Clobazam, the night they start clobazam and three months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJul 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Electrical Status Epilepticus in SleepStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck LLC
- Responsible party
- Principal investigator, Tobias Loddenkemper, Boston Children's Hospital
- Investigators
- Tobias Loddenkemper, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127918
- Sponsor's protocol ID
- BCH-P00003255
- Other IDs
- IND 117060
- Acronym
- ESES-Clobazam
- Status last verified
- Jul 2015
- First submitted
- 27 Jan 2014
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez IS, Chapman KE, Peters JM, Kothare SV, Nordli DR Jr, Jensen FE, Berg AT, Loddenkemper T. The tower of Babel: survey on concepts and terminology in electrical status epilepticus in sleep and continuous spikes and waves during sleep in North America. Epilepsia. 2013 Apr;54(4):741-50. doi: 10.1111/epi.12039. Epub 2012 Nov 16.
PubMed 23163318Chavakula V, Sanchez Fernandez I, Peters JM, Popli G, Bosl W, Rakhade S, Rotenberg A, Loddenkemper T. Automated quantification of spikes. Epilepsy Behav. 2013 Feb;26(2):143-52. doi: 10.1016/j.yebeh.2012.11.048. Epub 2013 Jan 3.
PubMed 23291250Sanchez Fernandez I, Loddenkemper T, Peters JM, Kothare SV. Electrical status epilepticus in sleep: clinical presentation and pathophysiology. Pediatr Neurol. 2012 Dec;47(6):390-410. doi: 10.1016/j.pediatrneurol.2012.06.016.
PubMed 23127259Fernandez IS, Peters JM, Hadjiloizou S, Prabhu SP, Zarowski M, Stannard KM, Takeoka M, Rotenberg A, Kothare SV, Loddenkemper T. Clinical staging and electroencephalographic evolution of continuous spikes and waves during sleep. Epilepsia. 2012 Jul;53(7):1185-95. doi: 10.1111/j.1528-1167.2012.03507.x. Epub 2012 May 11.
PubMed 22578248Fernandez IS, Peters J, Takeoka M, Rotenberg A, Prabhu S, Gregas M, Riviello JJ Jr, Kothare S, Loddenkemper T. Patients with electrical status epilepticus in sleep share similar clinical features regardless of their focal or generalized sleep potentiation of epileptiform activity. J Child Neurol. 2013 Jan;28(1):83-9. doi: 10.1177/0883073812440507. Epub 2012 Apr 24.
PubMed 22532549Sanchez Fernandez I, Hadjiloizou S, Eksioglu Y, Peters JM, Takeoka M, Tas E, Abdelmoumen I, Rotenberg A, Kothare SV, Riviello JJ Jr, Loddenkemper T. Short-term response of sleep-potentiated spiking to high-dose diazepam in electric status epilepticus during sleep. Pediatr Neurol. 2012 May;46(5):312-8. doi: 10.1016/j.pediatrneurol.2012.02.017.
PubMed 22520353Loddenkemper T, Fernandez IS, Peters JM. Continuous spike and waves during sleep and electrical status epilepticus in sleep. J Clin Neurophysiol. 2011 Apr;28(2):154-64. doi: 10.1097/WNP.0b013e31821213eb.
PubMed 21399511Tassinari CA, Cantalupo G, Rios-Pohl L, Giustina ED, Rubboli G. Encephalopathy with status epilepticus during slow sleep: "the Penelope syndrome". Epilepsia. 2009 Aug;50 Suppl 7:4-8. doi: 10.1111/j.1528-1167.2009.02209.x.
PubMed 19682041Tassinari CA, Rubboli G, Volpi L, Meletti S, d'Orsi G, Franca M, Sabetta AR, Riguzzi P, Gardella E, Zaniboni A, Michelucci R. Encephalopathy with electrical status epilepticus during slow sleep or ESES syndrome including the acquired aphasia. Clin Neurophysiol. 2000 Sep;111 Suppl 2:S94-S102. doi: 10.1016/s1388-2457(00)00408-9.
PubMed 10996561De Negri M. Electrical status epilepticus during sleep (ESES). Different clinical syndromes: towards a unifying view? Brain Dev. 1997 Nov;19(7):447-51.
PubMed 9408589De Negri M, Baglietto MG, Battaglia FM, Gaggero R, Pessagno A, Recanati L. Treatment of electrical status epilepticus by short diazepam (DZP) cycles after DZP rectal bolus test. Brain Dev. 1995 Sep-Oct;17(5):330-3. doi: 10.1016/0387-7604(95)00076-n.
PubMed 8579219Kramer U, Sagi L, Goldberg-Stern H, Zelnik N, Nissenkorn A, Ben-Zeev B. Clinical spectrum and medical treatment of children with electrical status epilepticus in sleep (ESES). Epilepsia. 2009 Jun;50(6):1517-24. doi: 10.1111/j.1528-1167.2008.01891.x. Epub 2008 Nov 19.
PubMed 19054417
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Status Epilepticus in Sleep: Response of Neuropsychological Deficits and Epileptiform Activity to Clobazam Treatment
- ClinicalTrials.gov ID
- NCT02127918
- Acronym / sponsor ID
- ESES-Clobazam / BCH-P00003255
- Conditions
- Electrical Status Epilepticus in Sleep
- Keywords
- Electrical status epilepticus in sleep, Continuous spikes and waves during sleep, Children, Electroencephalogram, Neuropsychology, Development, Antiepileptic drugs, Clobazam
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Lundbeck LLC
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 May 2014 (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.
Electrical status epilepticus in sleep (ESES) is a pattern of abnormal discharges in the electroencephalogram (EEG). Children who have this pattern present seizures and neuropsychological regression. There are no studies that systematically evaluate the response of abnormal discharges in the EEG, seizures and neuropsychological regression to different antiepileptic treatments. Therefore, treatment strategies in ESES are not based on scientific evidence. High-dose benzodiazepines such as diazepam (valium) have been reported to improve the severe EEG abnormalities of patients with ESES in the short-term. But the long-term response of seizures and neuropsychological regression has not been systematically studied. Clobazam is a benzodiazepine derivative with antiepileptic properties. The pharmacologic properties of clobazam make of this drug a particularly useful option in ESES: in patients with ESES the alpha-2 subunit of the GABA receptor is preferentially up-regulated and clobazam may have a higher affinity for this particular subunit, so investigators expect a higher effect of this drug on ESES patients than with other benzodiazepines (Loddenkemper et al, in preparation). The aim of our study is to objectively evaluate the response to clobazam treatment of neuropsychological deficits, seizures and abnormal discharges in the EEG in patients with ESES. Clobazam treatment is used in routine clinical practice and investigators will objectively quantify its effect.
Our working hypothesis is that high-dose clobazam treatment may control the abnormal epileptiform discharges in the EEG in patients with ESES. The reduction in abnormal epileptiform discharges may lead to an improvement in neuropsychological deficits and seizures. The predicted improvement in seizures and neuropsychological function would lead to a better quality of life in these patients.
Detailed description
- A. RESEARCH METHODS
Study design. Investigators will perform a prospective descriptive cohort study with historical controls.
Participating institutions. Children's Hospital Boston (PI: Tobias Loddenkemper) and Children's Hospital Colorado (PI: Kevin Chapman).
Patients. Investigators will enroll patients with ESES studied at our centers and treated with high-dose clobazam treatment as decided by the clinical epileptologist.
The diagnosis of ESES will be confirmed based on neuropsychological regression in at least one domain of development, the presence of seizures that appear in an age-related manner and the presence in the EEG of the ESES pattern (Loddenkemper, et al. 2011a).
Contact with the patients. Once that the potential candidate is recognized (patient with ESES, a change in medication regimen is decided that includes initiation of clobazam), the research team will contact the primary epileptologist. The primary epileptologist will contact the patient in order to check whether the family and/or patient would like to be contacted for this research protocol. If the patient agrees to be contacted, the research team will contact the patient in order to propose them to participate in the study.
EEG assessment. Investigators will assess the epileptiform activity in the long-term monitoring unit before and after treatment for every patient.Assessment of clinical data. The clinical charts of the patients included in the study will be collected reviewed for relevant clinical information. This information will be updated and complemented with the patient and/or the family during the admissions for long-term monitoring. Assessment of neuropsychological data: A battery of neuropsychological tests will be performed by board-certified clinical neuropsychologists to obtain information regarding cognitive abilities.
Safety measures. Investigators will continuously monitor patients for adverse effects during hospitalization and provide them with contact information for continuous report of possible adverse effects. Potential risk to subjects. As subjects will be using a FDA-approved drug for the treatment of epilepsy their risk will be the same as in routine clinical care. There will not be risks associated with the specific use of clobazam as it is routinely used for clinical care and the decision to use it or not will depend on the primary provider and not on the research team. Other potential risks are related with the loss of privacy and confidentiality. Investigators will develop mechanisms to ensure protection of patients' privacy and confidentiality.
Quality control method. Investigators will perform quality control measures every 5 collected patients at Children's Hospital Boston. Additionally, independent medical monitoring will be implemented.
- B. STATISTICAL ANALYSIS
Calculation of the sample size. Our previous study with diazepam treatment (Sánchez Fernández, et al. in press-a) found that the difference in epileptiform activity before and after treatment was of around 30%. There are no other data available on the quantification of the response of epileptiform activity to antiepileptic treatment.
- C. PLANS FOR MISSING DATA
Recruitment of patients. Patients with ESES frequently belong to the category of patients that are not able to understand the study protocol both because of their age and because of neuropsychological regression. Their families and/or caretakers will decide in most cases about study enrollment and the patient consent/assent will be looked for when developmentally possible. Although studies with patients with severe developmental delays pose significant challenges, the burden of participating in the study will not be significantly different from the burden of normal clinical care. Additionally this study will be performed at centers that are familiar with the care of patients with severe developmental delay.
Sample size. Power calculation for the proposed study is challenging due to the novel approach. Our preliminary data, however, strongly favor feasibility and completion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESES treated with clobazam | – | Drug: ESES treated with clobazamThe patients that will participate in the protocol will be those that are administered for clinical reasons oral clobazam. |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Investigators will enroll patients with ESES studied at our centers and treated with high-dose clobazam treatment as decided by the clinical epileptologist. Patients with ESES are monitored once or twice a year in the long-term electroencephalogram monitoring unit to assess epileptiform activity. Patients with very active discharges and neuropsychological regression require a change in their treatment regimen. If the treating epileptologist decides that high-dose cloblazam treatment is indicated for clinical reasons, then the patient will be offered to participate in the study. The research team will not be responsible for or influence the treatment decisions in any way.
Key inclusion criteria (2 listed)
- A change in treatment regimen is required because of very active epileptiform activity during sleep and neuropsychological regression. This means that only patients with very active epileptiform activity and, therefore, with a need for a change in treatment regimen as clinically indicated will be potentially eligible. Additionally, a prior clinical decision to use clobazam should have been made by the primary epileptologist in order to participate in the study.
- Availability for clinical, neuropsychological and EEG follow-up.
Key exclusion criteria (1 listed)
- Electro-clinical evolution that does not require a change in medication regimen or changes in medication regimen that do not include clobazam.
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 |
|---|---|---|
| ESES treated with clobazamThe patients that will participate in the protocol will be those that are administered for clinical reasons oral clobazam. | Drug | ESES treated with clobazam |
Primary outcome
Cognitive ability
Time frame: Measured the day before and 3 months after starting treatment
A neuropsycholgist will assess the patient's change in cognitive ability in response to treatment with clobazam using theDifferential Ability Scales- Second Edition.
Language
Time frame: Measured the day before and 3 months after starting treatment.
A neuropsychologist will assess the patient's change in language ability in response to clobazam using the Peabody Picture Vocabulary Test-Fourth Edition, Word Generation and NEPSY: A Developmental Neuropsychological Assessment-Second Edition.
Executive function
Time frame: Measured the day before and 3 months after starting clobazam
A parent will fill out the Behavior Rating Inventory of Executive Function, and CogState, to assess the patient's change in executive function in response to clobazam.
Adaptive/development skills
Time frame: Measured the day before and three months after starting clobazam
A parent will fill out the Scales of Independent Behaviors-Revised and The Developmental Profile-Third Edition to assess the patient's adaptive/developmental skills.
Behavior
Time frame: Measured the day before and three months after starting clobazam
The parent will fill out the Child Behavior Checklist to assess the patient's behavior change in response to clobazam.
1 secondary outcome
Interictal epileptiform activity
Time frame: The night before the patient starts Clobazam, the night they start clobazam and three months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Background: PubMed 23163318Fernandez IS, Chapman KE, Peters JM, Kothare SV, Nordli DR Jr, Jensen FE, Berg AT, Loddenkemper T. The tower of Babel: survey on concepts and terminology in electrical status epilepticus in sleep and continuous spikes and waves during sleep in North America. Epilepsia. 2013 Apr;54(4):741-50. doi: 10.1111/epi.12039. Epub 2012 Nov 16.
- Background: PubMed 23291250Chavakula V, Sanchez Fernandez I, Peters JM, Popli G, Bosl W, Rakhade S, Rotenberg A, Loddenkemper T. Automated quantification of spikes. Epilepsy Behav. 2013 Feb;26(2):143-52. doi: 10.1016/j.yebeh.2012.11.048. Epub 2013 Jan 3.
- Background: PubMed 23127259Sanchez Fernandez I, Loddenkemper T, Peters JM, Kothare SV. Electrical status epilepticus in sleep: clinical presentation and pathophysiology. Pediatr Neurol. 2012 Dec;47(6):390-410. doi: 10.1016/j.pediatrneurol.2012.06.016.
- Background: PubMed 22578248Fernandez IS, Peters JM, Hadjiloizou S, Prabhu SP, Zarowski M, Stannard KM, Takeoka M, Rotenberg A, Kothare SV, Loddenkemper T. Clinical staging and electroencephalographic evolution of continuous spikes and waves during sleep. Epilepsia. 2012 Jul;53(7):1185-95. doi: 10.1111/j.1528-1167.2012.03507.x. Epub 2012 May 11.
- Background: PubMed 22532549Fernandez IS, Peters J, Takeoka M, Rotenberg A, Prabhu S, Gregas M, Riviello JJ Jr, Kothare S, Loddenkemper T. Patients with electrical status epilepticus in sleep share similar clinical features regardless of their focal or generalized sleep potentiation of epileptiform activity. J Child Neurol. 2013 Jan;28(1):83-9. doi: 10.1177/0883073812440507. Epub 2012 Apr 24.
- Background: PubMed 22520353Sanchez Fernandez I, Hadjiloizou S, Eksioglu Y, Peters JM, Takeoka M, Tas E, Abdelmoumen I, Rotenberg A, Kothare SV, Riviello JJ Jr, Loddenkemper T. Short-term response of sleep-potentiated spiking to high-dose diazepam in electric status epilepticus during sleep. Pediatr Neurol. 2012 May;46(5):312-8. doi: 10.1016/j.pediatrneurol.2012.02.017.
- Background: PubMed 21399511Loddenkemper T, Fernandez IS, Peters JM. Continuous spike and waves during sleep and electrical status epilepticus in sleep. J Clin Neurophysiol. 2011 Apr;28(2):154-64. doi: 10.1097/WNP.0b013e31821213eb.
- Background: PubMed 19682041Tassinari CA, Cantalupo G, Rios-Pohl L, Giustina ED, Rubboli G. Encephalopathy with status epilepticus during slow sleep: "the Penelope syndrome". Epilepsia. 2009 Aug;50 Suppl 7:4-8. doi: 10.1111/j.1528-1167.2009.02209.x.
- Background: PubMed 10996561Tassinari CA, Rubboli G, Volpi L, Meletti S, d'Orsi G, Franca M, Sabetta AR, Riguzzi P, Gardella E, Zaniboni A, Michelucci R. Encephalopathy with electrical status epilepticus during slow sleep or ESES syndrome including the acquired aphasia. Clin Neurophysiol. 2000 Sep;111 Suppl 2:S94-S102. doi: 10.1016/s1388-2457(00)00408-9.
- Background: PubMed 9408589De Negri M. Electrical status epilepticus during sleep (ESES). Different clinical syndromes: towards a unifying view? Brain Dev. 1997 Nov;19(7):447-51.
- Background: PubMed 8579219De Negri M, Baglietto MG, Battaglia FM, Gaggero R, Pessagno A, Recanati L. Treatment of electrical status epilepticus by short diazepam (DZP) cycles after DZP rectal bolus test. Brain Dev. 1995 Sep-Oct;17(5):330-3. doi: 10.1016/0387-7604(95)00076-n.
- Background: PubMed 19054417Kramer U, Sagi L, Goldberg-Stern H, Zelnik N, Nissenkorn A, Ben-Zeev B. Clinical spectrum and medical treatment of children with electrical status epilepticus in sleep (ESES). Epilepsia. 2009 Jun;50(6):1517-24. doi: 10.1111/j.1528-1167.2008.01891.x. Epub 2008 Nov 19.
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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.
Tobias Loddenkemper, MD principal investigator
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrical Status Epilepticus in Sleep, run by Boston Children's Hospital at 2 sites in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive ability (time frame: Measured the day before and 3 months after starting treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127918, which also lists 12 linked publications.
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 30 Jul 2015.