Focal Epilepsy
Conditions
Interventions
20mg:CB03-154
Placebo:Placebo
10mg:CB03-154
5mg:CB03-154
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Ability of the subjects or his/her authorized representative be fully informed of the nature and risks of the study and give informed consent in writing prior to entering the study. 2. Male and female aged 18 to 70 years, inclusive. 3. 18.0 kg/m^2 =2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017). 5. Prior neuroimaging within the last 5 years prior to screening and documentation are available to rule out progressive structural central nervous system abnormalities . 6. Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the DBP. 7. In the three months prior to screening and during the 8-weeks baseline period, subjects must have at least 6 focal seizures without status epilepticus, with or without focal to bilateral tonic-clonic, the seizures interval of greater than 15 minutes. 8. If a female, must be: •Postmenopausal, defined as amenorrhea for at least 12 months, and confirmed by blood follicle stimulating hormone (FSH) at Screening, OR •Surgically sterile with a documented hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening, OR •If of child-bearing potential, heterosexually active females with male partners must be using an acceptable and highly effective method of contraception as required in section 5.4 of the protocol starting at least one menstrual cycle before first study drug administration and continuing until at least 3 months after the last dose of the study drug. If a female subject is abstinent, she must agree to use an acceptable and highly effective form of birth control as above once she becomes heterosexually active during the study. 9. If a female of child-bearing potential, must have a negative pregnancy test result at Screening and Check-in. 10. If a male, if heterosexually sexually active with a female partner of child-bearing potential and has not had a vasectomy, must agree to use a highly effective method of contraception as required in section 5.4 of the protocol and deemed appropriate by the Investigator and must not donate sperm during the study and for 3 months after the last dose of study drug. 11. Able to keep accurate seizure diaries.
Exclusion criteria
Exclusion criteria: 1. Subject has had documented previous EEGs indicating other patterns of epilepsy besides the focal epilepsy prior to dosing the study drug. 2. Subject has seizures secondary to drugs or alcohol use, ongoing infection, metabolic diseases or progressive central nervous system diseases or lesions at the investigator’s assessments. 3. Subject has the history of pseudoseizures, conversion disorders, or other non-epileptic seizure conditions, or other nonepileptic ictal events that could be confused with seizures at the investigator’s discretion and/or EEG evidence. 4. Subject has the presence or previous history of Lennox-Gastaut syndrome, some other related syndrome or evidence of both focal and generalized epilepsy at investigator’s decisions. 5. Subject has the history of status epilepticus within 6 months prior to screening. 6. Subject has only uncountably repetitive seizures occurring within 6 months prior to screening. 7. Subject has the history of neurosurgery for seizures 450 msec prior to first dose of the study drug;a family history of long QT syndromes or sudden death of unknown cause;Bundle branch blocks or atrioventricular or other conduction abnormalities that are clinically significant according to the Investigator and/or with a PR interval >=220ms, or HR 2.0 Upper limit of normal (ULN) of blood D-Dimer, or >1.5 Upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), amylase (AMY) prior to first dose of the study drug. If subject has >ULN of above laboratory tests that does not meet the exclusion limit at screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase at the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median percent change (MPC) in the frequency of focal baseline pain episodes;Severity and incidence of related adverse events (AE) and serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactPemin Yu, Hong Zhen
Huashan Hospital, Fudan University
Outcome results
None listed