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

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ClinicalTrials.gov Identifier: NCT02904265
Recruitment Status : Terminated (Lack of enrollment)
First Posted : September 16, 2016
Last Update Posted : October 8, 2019
Sponsor:
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. Spike wave index (SWI) reduction seen in children on acetazolamide [ Time Frame: within first 4-6 weeks after starting therapy with acetazolamide ]
    Similar SWI reductions (percentage) comparing acetazolamide and diazepam


Secondary Outcome Measures :
  1. Improvement in behaviors (attention, hyperactivity) [ Time Frame: within 4-8 weeks of initiation of acetazolamide ]
  2. Improvement in cognitive regression [ Time Frame: within 4-8 weeks of initiation of acetazolamide ]
  3. Long term tolerability to acetazolamide [ Time Frame: 6 months ]
    Expect minimal side effects at follow up at 6 months

  4. 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

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02904265


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Katherine C. Nickels, M.D. Mayo Clinic

Publications:
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Responsible Party: Katherine C. Nickels, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02904265     History of Changes
Other Study ID Numbers: 16-002442
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
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
acetazolamide
diazepam
Additional relevant MeSH terms:
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Status Epilepticus
Landau-Kleffner Syndrome
Syndrome
Disease
Pathologic Processes
Seizures
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epileptic Syndromes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Acetazolamide
Diazepam
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central