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

Landau-Kleffner Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02904265
• Other study ID #: 16-002442
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: September 2016
• Est. completion date: July 26, 2019

Study information

• Verified date: May 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: July 26, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Landau-Kleffner Syndrome
• Status Epilepticus
• Status Epilepticus, Electrographic
• Syndrome

Intervention

Drug:
• Diazepam

• Acetazolamide

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (6)

De Negri M, Baglietto MG, Battaglia FM, Gaggero R, Pessagno A, Recanati L. Treatment of electrical status epilepticus by short diazepam (DZP) cycles after DZP rectal bolus test. Brain Dev. 1995 Sep-Oct;17(5):330-3. — View Citation

Fine AL, Wirrell EC, Wong-Kisiel LC, Nickels KC. Acetazolamide for electrical status epilepticus in slow-wave sleep. Epilepsia. 2015 Sep;56(9):e134-8. doi: 10.1111/epi.13101. Epub 2015 Jul 31. — View Citation

Francois D, Roberts J, Hess S, Probst L, Eksioglu Y. Medical management with diazepam for electrical status epilepticus during slow wave sleep in children. Pediatr Neurol. 2014 Mar;50(3):238-42. doi: 10.1016/j.pediatrneurol.2013.11.002. Epub 2013 Nov 12. — View Citation

Katayama F, Miura H, Takanashi S. Long-term effectiveness and side effects of acetazolamide as an adjunct to other anticonvulsants in the treatment of refractory epilepsies. Brain Dev. 2002 Apr;24(3):150-4. — View Citation

Sánchez Fernández I, Peters JM, An S, Bergin AM, Takeoka M, Rotenberg A, Kothare SV, Riviello JJ Jr, Loddenkemper T. Long-term response to high-dose diazepam treatment in continuous spikes and waves during sleep. Pediatr Neurol. 2013 Sep;49(3):163-170.e4. doi: 10.1016/j.pediatrneurol.2013.04.027. — View Citation

Wirrell E, Ho AW, Hamiwka L. Sulthiame therapy for continuous spike and wave in slow-wave sleep. Pediatr Neurol. 2006 Sep;35(3):204-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials