Long-term Open-label Study to Evaluate Safety, Tolerability, and Effectiveness of CB03-154 in Adults With Focal Epilepsy

What this Trial Is About

Researchers are evaluating CB03-154, an investigational drug developed by Shanghai Zhimeng Biopharma Inc., for the treatment of focal epilepsy. This open-label extension study follows a Phase 2 trial and aims to assess the long-term safety, tolerability, efficacy, and pharmacokinetics of CB03-154 when given orally once daily to patients with epilepsy. Only patients who successfully completed the prior study without early discontinuation are eligible to participate. Participants will start with a two-week course of CB03-154 at 10 mg once daily. If the medication is well tolerated, the dose will be increased to 20 mg once daily and continued for up to two years. This study focuses on long-term treatment and monitoring of patients who have already been treated in the previous trial. Throughout the study, participants will be monitored for safety, tolerability, and effectiveness of CB03-154, including the measurement of plasma drug concentration at specified weeks. Patients will keep seizure diaries and attend regular visits during the treatment period, which lasts up to 104 weeks, followed by an 8-week post-treatment follow-up. The study will evaluate how well patients tolerate the drug and its long-term impact on epilepsy symptoms.

An Open-label Study to Evaluate Safety, Tolerability, and Efficacy of CB03-154 in Subjects Diagnosed With Epilepsy