CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.
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.
Male and female aged 18 to 70 years, inclusive.
18.0 kg/m2 ≤BMI ≤ 34.0 kg/m2.
Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy [ILAE] Classification of Epilepsy (2017).
Subject has had documented previous EEGs indicating other patterns of epilepsy besides the focal epilepsy prior to dosing the study drug.
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.
Subject has the history of pseudo seizures, conversion disorders, or other non-epileptic seizure conditions, or other non-epileptic ictal events that could be confused with seizures at the investigator's discretion and/or EEG evidence.
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.
Parallel
Test drug CB03-154 5mg group
DrugCB03-154 tablet (5mg/tablet) once daily.
Test drug CB03-154 10mg group
DrugTwo CB03-154 tablets (5mg/tablet) once daily.
Test drug CB03-154 20mg group
DrugFour CB03-154 tablets (5mg/tablet) once daily.
Placebo group
DrugFour Placebo tablets once daily.
To assess the efficacy of CB03-154 compared to placebo on focal seizure frequency in adults with focal epilepsy taking 1 to 3 AEDs in the double-blind period (DBP).
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to the entire period of DBP for CB03-154 versus placebo.
To assess the safety and tolerability by evaluating the frequency and severity of adverse events (AEs) /serious adverse events (SAEs) of CB03-154 in adults with focal epilepsy taking 1 to 3 AEDs in the DBP.
Severity and frequency/incidence of associated AEs/serious adverse events (SAEs).
To evaluate the 50% CB03-154 response rates in comparison to placebo in the DBP.
Proportion of responders, defined as experiencing ≥50% reduction in monthly (28 days) focal seizure frequency at baseline compared to the entire period of DBP.
To evaluate trends in focal seizure frequency over time in the DBP.
Percent change from baseline in weekly focal seizure frequency for each week of the DBP.
Maximum Plasma Concentration (Cmax).
For all subjects, blood will be collected on Day 7, Day 15, Day 29, and Day 85 in the period of double-blind period for plasma concentration measurement.
Use the Hamilton Depression Rating Scale (HAMD-17) to assess the effect of CB03-154 vs placebo on seizure severity and impact in adults with focal epilepsy taking 1 to 3 AEDs in the DBP.
To assess the change from baseline to the end of DBP in the Hamilton Depression Rating Scale (HAMD-17) total score during the DBP. The total score can better reflect the severity of depression, the lighter the illness, the lower the total score. A score above 24 was severe depression, 17 to 24 was moderate depression, 7 to 17 was mild depression, and a score below 7 was no depressive symptoms.
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