Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome

Study Overview
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Brief Summary
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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).

Official Title
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Non-inferiority Prospective Randomized Trial of Acetazolamide Versus Diazepam in Patients With Continuous Spike and Wave in Sleep (CSWS)/Landau Kleffner Syndrome (LKS)

Conditions
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Landau-Kleffner Syndrome, Status Epilepticus, Electrographic

Intervention / Treatment
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* Drug: Diazepam
* Drug: Acetazolamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diazepam<br>Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks. | Drug: Diazepam<br> <br> * Other names: Valium;|
| Experimental: Acetazolamide<br>Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks. | Drug: Acetazolamide<br> <br> * Other names: Diamox Sequels;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-term Tolerability of Acetazolamide vs Diazepam | Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up | 4-8 weeks of start of medications | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous spike wave in sleep, Landau-Kleffner syndrome, acetazolamide, diazepam