Landau-Kleffner Syndrome, Status Epilepticus, Electrographic
Conditions
Keywords
continuous spike wave in sleep, Landau-Kleffner syndrome, acetazolamide, diazepam
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).
Interventions
DRUGDiazepam
DRUGAcetazolamide
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Study closed due to only 3 participants recruited
Pre-assignment details
Study closed due to only 3 participants recruited
Participants by arm
| Arm | Count |
|---|---|
| Diazepam Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks. | 1 |
| 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.
Acetazolamide | 2 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 2 |
Baseline characteristics
| Characteristic | Acetazolamide | Total | Diazepam |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 3 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 2 years | 1.5 years | 1 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 2 participants | 2 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 2 |
| other Total, other adverse events | 0 / 1 | 0 / 2 |
| serious Total, serious adverse events | 0 / 1 | 0 / 2 |
Outcome results
Primary
Short-term Tolerability of Acetazolamide vs Diazepam
Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up
Time frame: 4-8 weeks of start of medications
Population: Study closed due to only 3 participants recruited
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diazepam | Short-term Tolerability of Acetazolamide vs Diazepam | 1 Participants |
| Acetazolamide | Short-term Tolerability of Acetazolamide vs Diazepam | 2 Participants |