EpilepsyNCT04737837
A Real World Study on the Efficacy and Safety of Lacosamide as Add-on Therapy for Focal-onset Epilepsy
An observational study of Epilepsy and Focal-Onset Seizure, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 19 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 to 75 years
- Conditions the study is for
- Epilepsy, Focal-Onset Seizure
- What is being tested?
- lacosamide
- How many people
- 200 participants
- Where
- 19 sitesChina
- Study dates
- 31 Jan 2021to 28 Feb 2022
- How long will I take part?
- 26 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and children patients (aged 4~75 years) with uncontrolled focal onset seizures and receiving only one baseline AED
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Beijing Children's Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality
Fang Fang
The First Hospital of Jilin University
Changchun, Jilin
Xiangya Hospital of Central South University
Changsha, Hunan
Peng Jing
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Wu Xintong, Doctor, 13882269092, 36853839@qq.com
West China Second Hospital of Sichuan University
Chengdu, Sichuan
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong
Qin bing, Doctor
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Weiping Liao, Doctor
Children's Hospital Affiliated to Medical College of Zhejiang University
Hangzhou, Zhejiang
Gao feng
Shandong Provincial Hospital
Jinan, Shandong
Gao yuxing
Nanjing Brain Hospital
Nanjing, Jiangshu
Rui Zhang
Huashan hospital affiliated to Fudan University
Shanghai, Shanghai Municipality
The Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Zhou Shuizhen
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Zhao Chuansheng
Shenzhen Children's Hospital
Shenzhen, Guangdong
Liao Jianxiang
The Children's Hospital Affiliated to Suzhou University
Suzhou, Jiangshu
Tang Jihong
Wuhan Union Hospital
Wuhan, Hubei
Xuejun Deng
Wuhan Children's Hospital
Wuhan, JiangShu
Sun Dan
The Second Affiliated Hospital of Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi
Shaoping Huang
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: 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
Read the 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.
- Conditions
- Epilepsy, Focal-Onset Seizure
- Being tested
- lacosamide
- Keywords
- focal onset,lacosamide,CEA,Real-world,first add on
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lacosamideDrug
Also called Xinkang
lacosamide as first add on therapy
| Study group | Role | What they receive |
|---|---|---|
| children | Children aged 4~16 years with focal onset seizures Receives: Drug: lacosamide | |
| Adult | Adults aged >16 years with focal onset seizures Receives: Drug: lacosamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 26 weeks
Secondary outcomes (6)
Seizure freedom rate
percentage of subjects who achieved seizure-free during maintenance period
Measured: up to 26 weeks
Retention rate
the percentage of patients continuing lacosamide at the end of a specified period
Measured: 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) ;
Measured: 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)
Measured: up to 26 weeks
Evaluation for anxiety status
using by seven-item Generalized Anxiety Disorder scale (GAD-7)
Measured: up to 24 weeks
Evaluation for depression status
using by Neurological Disorders Depression Inventory for Epilepsy(NDDI-E)
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start31 Jan 2021 (estimated)
- Primary completion28 Nov 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 26 Weeks
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Zhou, Doctor, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737837
- Sponsor's protocol ID
- QF-LCM2020-1
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04737837
- Acronym / sponsor ID
- QF-LCM2020-1
- Conditions
- Epilepsy, Focal-Onset Seizure
- Keywords
- focal onset,lacosamide,CEA,Real-world,first add on
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2021 (estimated)
- Primary completion
- 28 Nov 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 26 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children | – | Drug: lacosamideChildren aged 4~16 years with focal onset seizures |
| Adult | – | Drug: lacosamideAdults aged >16 years with focal onset seizures |
Who may qualify
- Ages
- 4 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and children patients (aged 4~75 years) with uncontrolled focal onset seizures and receiving only one baseline AED
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lacosamideAlso: Xinkanglacosamide as first add on therapy | Drug | Adult, children |
Primary outcome
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
≥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
6 secondary outcomes
Seizure freedom rate
Time frame: up to 26 weeks
Retention rate
Time frame: up to 26 weeks
Cognitive function
Time frame: up to 26 weeks
Cognitive function
Time frame: up to 26 weeks
Evaluation for anxiety status
Time frame: up to 24 weeks
Evaluation for depression status
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Zhou, Doctor principal investigator
West China Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Focal-Onset Seizure, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruipeng Zhang, MA (13654951067, zhangruipeng@qfyy.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in seizure frequency per 4 week from retrospective baseline to the maintenance period (time frame: up to 26 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.