Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Synd… (NCT02904265) | Clinical Trial Compass
TerminatedPhase 2/3
Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome
Stopped: Lack of enrollment
United States3 participantsStarted 2016-09
Plain-language 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).
Who can participate
Age range
3 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — do you know why it ended early, and does that affect what we can learn from it about using acetazolamide or diazepam for my child's condition?
2Since this was a Phase 2/3 study comparing acetazolamide to diazepam, and it was primarily measuring short-term tolerability rather than long-term outcomes, how much do we actually know about whether either drug is effective for Landau-Kleffner Syndrome or continuous spike and wave?
3Given that the trial was terminated, are there other ongoing or completed studies you would recommend looking at before deciding between acetazolamide and diazepam as treatment options?
4Since this trial focused on tolerability — meaning side effects and how well patients handled each drug — what do you know about the safety profile of acetazolamide compared to diazepam specifically for someone with Landau-Kleffner Syndrome or electrographic status epilepticus?
5Would standard treatment approaches for Landau-Kleffner Syndrome be a better starting point right now, given that this trial didn't fully complete and the evidence from it may be limited?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Short-term Tolerability of Acetazolamide vs Diazepam