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
1 other identifier
observational
200
1 country
19
Brief 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 real-world clinical setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2021
CompletedStudy Start
First participant enrolled
January 31, 2021
CompletedFirst Posted
Study publicly available on registry
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedFebruary 4, 2021
January 1, 2021
10 months
January 24, 2021
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Seizure freedom rate
up to 26 weeks
Retention rate
up to 26 weeks
Cognitive function
up to 26 weeks
Cognitive function
up to 26 weeks
Evaluation for anxiety status
up to 24 weeks
- +1 more secondary outcomes
Other Outcomes (2)
the Cost of epilepsy treatment
up to 26 weeks
Cost-Effectiveness Analysis(CEA）
up to 26 weeks
Study Arms (2)
children
Children aged 4\~16 years with focal onset seizures
Adult
Adults aged \>16 years with focal onset seizures
Interventions
Eligibility Criteria
Adult and children patients (aged 4\~75 years) with uncontrolled focal onset seizures and receiving only one baseline AED
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Beijing Children's Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen Children's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Union Hospital
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Brain Hospital
Nanjing, Jiangshu, China
The Children's Hospital Affiliated to Suzhou University
Suzhou, Jiangshu, China
Wuhan Children's Hospital
Wuhan, JiangShu, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
Huashan hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
The Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000, China
West China Second Hospital of Sichuan University
Chengdu, Sichuan, China
Children's Hospital Affiliated to Medical College of Zhejiang University
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Zhou, Doctor
West China Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 26 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2021
First Posted
February 4, 2021
Study Start
January 31, 2021
Primary Completion
November 28, 2021
Study Completion
February 28, 2022
Last Updated
February 4, 2021
Record last verified: 2021-01