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).
Full Title of Study: “Non-inferiority Prospective Randomized Trial of Acetazolamide Versus Diazepam in Patients With Continuous Spike and Wave in Sleep (CSWS)/Landau Kleffner Syndrome (LKS)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: July 26, 2019
- Drug: Diazepam
- Drug: Acetazolamide
Arms, Groups and Cohorts
- Active Comparator: Diazepam
- Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.
- Experimental: 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.
Clinical Trial Outcome Measures
- Short-term Tolerability of Acetazolamide vs Diazepam
- Time Frame: 4-8 weeks of start of medications
- Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 3 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Mayo Clinic
- Provider of Information About this Clinical Study
- Principal Investigator: Katherine C. Nickels, MD – Mayo Clinic
- Overall Official(s)
- Katherine C. Nickels, M.D., Principal Investigator, Mayo Clinic
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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.
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.
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.
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.
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