epilepsy
Conditions
Interventions
intervention group:lacosamide
Sponsors
West China Second Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
4 Years to 16 Years
Inclusion criteria
Inclusion criteria: 1. Aged > 4 years, and <=16 years. 2. Diagnosis of focal epilepsy with or without secondary generalized seizures. 3. Subjects currently use only one baseline AED other than lacosamide. 4. The subjects had epileptic seizures more than one time in the first three months of screening. 5. Informed consent to participate in research.
Exclusion criteria
Exclusion criteria: 1. Subjects had known allergies to any component of the drug under study. 2. Patients with uncertain seizure frequency in the first three months of admission. 3. Subjects participated in another trial drug (IMP) or medical device study within two months before the first visit, or are currently participating in another trial drug or medical device study. 4. Subjects had taken or participated in clinical trials of LCM and terminated because of lack of efficacy or adverse events. 5. Subjects suffer from any medical or psychiatric disorder that the researchers believe may endanger or impair their ability to participate in the study. 6. Subjects suffer from medical conditions that researchers believe are expected to interfere with the study of drug absorption, distribution, metabolism or excretion. 7. Subjects were receiving ketogenic diet therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 50% Response rate;Percentage of epilepsy without seizures; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average Decrease Percentage of Seizure Frequency; | — |
Countries
China
Contacts
Public ContactYu Dan
West China Second Hospital
Outcome results
None listed