Non-inferiority Prospective Randomized Trial of Acetazolamide Versus Diazepam in Patients With Continuous Spike and Wave in Sleep (CSWS)/Landau Kleffner Syndrome (LKS)
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Short-term Tolerability of Acetazolamide vs Diazepam
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diazepam
Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.
Intervention: Diazepam (Drug)
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.
Intervention: Acetazolamide (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Katherine C. Nickels
MD
Mayo Clinic