A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy

A Multi-center,Open-label Real-world Study to Evaluate the Efficacy and Pharmaco-economics of Lacosamide as First Add-on Therapy for Adults and Children With Focal Onset Seizures

The purpose of this trial is to evaluate the efficacy, safety, and pharmaco-economics of Lacosamide Tablet as first add-on therapy for uncontrolled focal onset epilepsy ,invetigating effects of lacosamide Tablet on cognitive function of children and anxiety and depression of adults with focal onset seizures In real-world clinical setting

Study Overview

• Status: Unknown
• Conditions: Epilepsy; Focal-Onset Seizure
• Intervention / Treatment: Drug: lacosamide

Detailed Description

In many real world, lacosamide as the first add-on therapy can significantly improve the seizure freedom rate. Moreover, many pharmacoeconomic studies in Sweden and the United States have confirmed that lacosamide is a more cost-effective option.This is a real-world study to evaluate the efficacy, safety and cost-effectiveness of Generic lacoxamide tablets in the treatment of patients with focal epilepsy. During the trial, patients with focal epilepsy were treated with lacosamide for the first time after the failure of the original antiepileptic drug. At the same time, the cost-effectiveness of Generic lacosamide was evaluated from the perspective of economics, in order to provide the basis for the clinical choice for Chinese epilepsy patients.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing Children's Hospital Affiliated to Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • The second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
    • Shenzhen, Guangdong, China
      • Shenzhen Children's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Union Hospital
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University
  • JiangShu
    • Wuhan, JiangShu, China
      • Wuhan Children's Hospital
  • Jiangshu
    • Nanjing, Jiangshu, China
      • Nanjing Brain Hospital
    • Suzhou, Jiangshu, China
      • The Children's Hospital Affiliated to Suzhou University
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Affiliated Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China
      • The Children's Hospital of Fudan University
  • Shanxi
    • Xi'an, Shanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University College of Medicine
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China
      • West China Second Hospital of Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Children's Hospital Affiliated to Medical College of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult and children patients (aged 4~75 years) with uncontrolled focal onset seizures and receiving only one baseline AED

Description

Inclusion Criteria:

• Before the start of the trial, to obtain the informed consent approved by the ethics committee voluntarily signed by each subject. For underage subjects, the informed consent jointly signed by the subjects themselves (≥10 years ) and their parents or legal guardian (in which the underage needs the signature with their parents or legal guardian, and the underage is defined as the subject under 18 years of age) ;
• Male and female, between the ages of 4 and 75 years;
• Diagnostic criteria of focal onset seizures (with or without focal to bilateral tonic clonic seizures) was based on the 2017 Classification of Epileptic Seizures from the International League Against Epilepsy (ILAE);
• In the 4 weeks before enrollment and during the baseline period, patients have been on only one stable dosage of antiepileptic drug and suitable for lacosamide add-on therapy according to their investigators criteria;
• During the 8-week retrospective baseline period, patients must have had at least 4 focal onset seizures per 28 days on average.

Exclusion Criteria:

• Patients had received previous lacosamide treatment;
• Female patients are pregnant, breast-feeding, and will not use contraception during the trial;
• Patients had known allergies to lacosamide or any ingredients of the drug, or with allergic constitution;
• Patients have a history of status epilepticus in the last 12 months;
• History of chronic alcohol or drug abuse; 6.history of suicide attempt or suicidal ideation in the past 6 months;
• Current use of Antidepressants, anxiolytics or antipsychotics;
• Patients suffer from progressive diseases that affect the patient's brain and its function;
• Sychogenic nonepileptic seizures;
• Patients suffer from serious lung and blood system diseases, malignant tumor, lower immune function and psychosis;
• Patients wil receive ketogenic diet therapy, or Four weeks before entering the screening period, patients used other drugs that may affect the absorption, distribution, metabolism and excretion of lacosamide, such as antipsychotics, monoamine oxidase inhibitors, barbiturates (except for combined use as anticonvulsant therapy), narcotic analgesics.
• Patients Had epilepsy brain surgery, or will undergo epilepsy surgery in the next four months.
• Investigators considered Patients as unsuitable for this trial.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
children; Children aged 4~16 years with focal onset seizures	Drug: lacosamide; lacosamide as first add on therapy; Other Names: Xinkang
Adult; Adults aged >16 years with focal onset seizures	Drug: lacosamide; lacosamide as first add on therapy; Other Names: Xinkang

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in seizure frequency per 4 week from retrospective baseline to the maintenance period	The seizure frequency is standardized to a 4 week duration	up to 26 weeks
≥50responder rate	percentage of subjects with a 50 % or greater reduction in seizure frequency per 4 weeks from retrospective baseline to maintenance	up to 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure freedom rate	percentage of subjects who achieved seizure-free during maintenance period	up to 26 weeks
Retention rate	the percentage of patients continuing lacosamide at the end of a specified period	up to 26 weeks
Cognitive function	Cognitive function in elderly children aged greater than or equal to 6 years is assessed by Wechsler Intelligence Scale for Children-Revised (WISC-RC) ;	up to 26 weeks
Cognitive function	Cognitive function in young children aged less than 6 years is assessed by Chinese Wechsler Young Children scale of Intelligence(C - WYCSI)	up to 26 weeks
Evaluation for anxiety status	using by seven-item Generalized Anxiety Disorder scale (GAD-7)	up to 24 weeks
Evaluation for depression status	using by Neurological Disorders Depression Inventory for Epilepsy(NDDI-E)	up to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the Cost of epilepsy treatment	To calculate the direct medical costs, including personal expenses and medical insurance reimbursement expenses, mainly include examination expenses, disposal expenses, medicine expenses, hospitalization expenses and other expenses	up to 26 weeks
Cost-Effectiveness Analysis(CEA）	CEA=cost/efficacy(C/E)	up to 26 weeks

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Dong Zhou, Doctor, West China Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 31, 2021
• Primary Completion (ANTICIPATED): November 28, 2021
• Study Completion (ANTICIPATED): February 28, 2022

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (ACTUAL): February 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: focal onset,lacosamide,CEA,Real-world,first add on
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lacosamide
• Other Study ID Numbers: QF-LCM2020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No