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

Mayo Clinic

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Landau-Kleffner Syndrome; Status Epilepticus, Electrographic

Treatments: Drug: Diazepam; Drug: Acetazolamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02904265

16-002442

Details and patient eligibility

About

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).

Enrollment: 3 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Diazepam

Active Comparator group

Description:

Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.

Treatment:

Drug: Diazepam

Acetazolamide

Experimental group

Description:

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.

Treatment:

Drug: Acetazolamide