Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Synd… (NCT02904265) | Clinical Trial Compass
TerminatedPhase 2/3
Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome
Stopped: Lack of enrollment
United States3 participantsStarted 2016-09
Plain-language summary
The purpose of this study is to compare the effectiveness of the medications acetazolamide and diazepam in the treatment of continuous spike wave in sleep (CSWS) and Landau-Kleffner syndrome (LKS).
Who can participate
Age range3 Years – 12 Years
SexALL
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Inclusion Criteria:
* ESES and clinical CSWS/LKS defined by all of the following:
* SWI ≥50% during first hour of sleep
* Bilateral synchrony of discharges during sleep
* Clinical evidence of behavior and/or academic regression
* Daytime SWI ≤20%
Exclusion Criteria:
* Previous treatment with benzodiazepine or acetazolamide for Electrical Status Epilepticus in Sleep (ESES)
* Current treatment with carbamazepine, phenytoin, oxcarbazepine, phenobarbital, vigabatrin or lamotrigine
* Antiepileptic medication changes over the month prior to enrollment
* Epileptic encephalopathy other than CSWS/LKS
* Prior serious adverse reaction to benzodiazepines or acetazolamide
* Sulfa allergy
* Progressive underlying neurologic condition
* Frequent seizures that would prevent the patient from maintaining a stable dose of medications
* Female patient that has begun menses or is pregnant
What they're measuring
1
Short-term Tolerability of Acetazolamide vs Diazepam