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

Phase 2

Terminated

• Conditions: Landau-Kleffner Syndrome; Status Epilepticus, Electrographic
• Interventions: Drug: Diazepam; Drug: Acetazolamide

• Registration Number: NCT02904265
• Lead Sponsor: Mayo Clinic

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Primary Completion: 2019-07-26
• Study Completion: 2019-07-26
• Results First Submitted: 2019-11-05
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-29
• Last Update Submitted: 2020-05-29
• Results First Posted: 2020-06-11
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Short-term Tolerability of Acetazolamide vs Diazepam	4-8 weeks of start of medications	Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States