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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02904265
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 16, 2016
Results First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
Katherine C. Nickels, Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Landau-Kleffner Syndrome Status Epilepticus, Electrographic Drug: Diazepam Drug: Acetazolamide Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : September 2016
Actual Primary Completion Date : July 26, 2019
Actual Study Completion Date : July 26, 2019

Arm Intervention/treatment
Active Comparator: Diazepam
Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.
Drug: Diazepam
Other Name: Valium

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.
Drug: Acetazolamide
Other Names:
  • Diamox
  • Diamox Sequels

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02904265

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Katherine C. Nickels, M.D. Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Katherine C. Nickels, Mayo Clinic:
Additional Information:
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Responsible Party: Katherine C. Nickels, MD, Mayo Clinic Identifier: NCT02904265    
Other Study ID Numbers: 16-002442
First Posted: September 16, 2016    Key Record Dates
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine C. Nickels, Mayo Clinic:
continuous spike wave in sleep
Landau-Kleffner syndrome
Additional relevant MeSH terms:
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Status Epilepticus
Landau-Kleffner Syndrome
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Epileptic Syndromes
Brain Diseases
Central Nervous System Diseases
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents