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NCT02127918 · ClinicalTrials.gov registry record
Electrical Status Epilepticus in Sleep: Response of Neuropsychological Deficits and Epileptiform Activity to Clobazam Treatment
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 17
- Enrollment target
NCT02127918: Completed study, sponsored by Boston Children's Hospital.
NCT02127918 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02127918 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
Study 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. 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.
Primary Outcome
A neuropsycholgist will assess the patient's change in cognitive ability in response to treatment with clobazam using theDifferential Ability Scales- Second Edition.
Interventions
- DRUG ESES treated with clobazam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2012-07 |
| Est. Completion | 2015-07 |
What the finished NCT02127918 record still lists
NCT02127918 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 17 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ESES treated with clobazam is the first listed.
NCT02127918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02127918 about?
NCT02127918 is a clinical study titled "Electrical Status Epilepticus in Sleep: Response of Neuropsychological Deficits and Epileptiform Activity to Clobazam Treatment". 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, se...
What is the current status of trial NCT02127918?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2012-07. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02127918?
The interventions under investigation include: ESES treated with clobazam (DRUG).
Who is sponsoring clinical trial NCT02127918?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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