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Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy

Zhejiang University logo

Zhejiang University

Status and phase

Unknown
Phase 4

Conditions

Epilepsy

Treatments

Drug: Placebo oral tablet
Drug: Lacosamide

Study type

Interventional

Funder types

Other

Identifiers

NCT04144218
IR20191016

Details and patient eligibility

About

Children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, EEG, MRI and 18F-FDG PET to determine the location of the epileptogenic focus and to assess the severity of the disease. This international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of LCM in clinical applications in children with epilepsy.

Enrollment

300 estimated patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of focal epilepsy with or without generalized seizures according to the 2017 International Association of Anti-Epilepsy (ILAE) classification 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

  • A history of status epilepticus within 3 months prior to screening visits.
  • Poor adherence to previous treatment.
  • Other serious organic diseases, mental illnesses and neurological diseases.
  • Abnormal liver and kidney function and blood routine results.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 2 patient groups, including a placebo group

Control group
Placebo Comparator group
Treatment:
Drug: Placebo oral tablet
Experimental group
Experimental group
Treatment:
Drug: Lacosamide

Trial contacts and locations

1

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Central trial contact

Jing Wang

Data sourced from clinicaltrials.gov

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