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

February 2, 2021 updated by: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The change in seizure frequency per 4 week from retrospective baseline to the maintenance period
Time Frame: up to 26 weeks
The seizure frequency is standardized to a 4 week duration
up to 26 weeks
≥50responder rate
Time Frame: up to 26 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Seizure freedom rate
Time Frame: up to 26 weeks
percentage of subjects who achieved seizure-free during maintenance period
up to 26 weeks
Retention rate
Time Frame: up to 26 weeks
the percentage of patients continuing lacosamide at the end of a specified period
up to 26 weeks
Cognitive function
Time Frame: up to 26 weeks
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
Time Frame: up to 26 weeks
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
Time Frame: up to 24 weeks
using by seven-item Generalized Anxiety Disorder scale (GAD-7)
up to 24 weeks
Evaluation for depression status
Time Frame: up to 24 weeks
using by Neurological Disorders Depression Inventory for Epilepsy(NDDI-E)
up to 24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the Cost of epilepsy treatment
Time Frame: up to 26 weeks
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）
Time Frame: up to 26 weeks
CEA=cost/efficacy(C/E)
up to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dong Zhou, Doctor, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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