Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
NCT ID: NCT04144218
Last Updated: 2020-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2019-11-08
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control group
Placebo oral tablet
The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
Experimental group
Lacosamide
The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
Interventions
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Lacosamide
The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
Placebo oral tablet
The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
Eligibility Criteria
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Inclusion Criteria
* Stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits.
* Seizure occurred during the 8-week retrospective baseline period with a complete medical record diary.
Exclusion Criteria
* Poor adherence to previous treatment.
* Other serious organic diseases, mental illnesses and neurological diseases.
* Abnormal liver and kidney function and blood routine results.
4 Years
18 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Michigan State University
OTHER
Juntendo University
OTHER
Technical University of Munich
OTHER
RIKEN
OTHER
University of California, Los Angeles
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IR20191016
Identifier Type: -
Identifier Source: org_study_id
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