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

• Status: Terminated
• Trial end date: 2019-07-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Acetazolamide; Diazepam

Criteria

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