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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02904265 |
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Date of registration:
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13/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome
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Scientific title:
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Non-inferiority Prospective Randomized Trial of Acetazolamide Versus Diazepam in Patients With Continuous Spike and Wave in Sleep (CSWS)/Landau Kleffner Syndrome (LKS) |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02904265 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Katherine C. Nickels, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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
Age minimum:
3 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Landau-Kleffner Syndrome
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Status Epilepticus, Electrographic
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Intervention(s)
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Drug: Acetazolamide
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Drug: Diazepam
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Primary Outcome(s)
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Short-term Tolerability of Acetazolamide vs Diazepam
[Time Frame: 4-8 weeks of start of medications]
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Secondary ID(s)
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16-002442
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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