NCT06612775

A Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 in Adult Patients With Focal Epilepsy

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 as Adjunctive Therapy in Focal Epilepsy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai Zhimeng Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Focal Epilepsy.

Detailed description

The purpose of this study is to evaluate the effectiveness of CB03-154 on focal seizure frequency by comparing with placebo, see how safe the study drug is and assess how well it is tolerated after dosing in adults with focal epilepsy taking 1 to 3 AEDs in the double-blind trial. The study will also test the 50% response rates of the study drug and see how it is taken up and eliminated by the body. An additional part of the study is to look how will the study drug influence the trends of frequency and seizure severity in the double-blind trial.

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
DRUG	Test drug CB03-154 5mg group	CB03-154 tablet (5mg/tablet) once daily.
DRUG	Test drug CB03-154 10mg group	Two CB03-154 tablets (5mg/tablet) once daily.
DRUG	Test drug CB03-154 20mg group	Four CB03-154 tablets (5mg/tablet) once daily.
DRUG	Placebo group	Four Placebo tablets once daily.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2024-09-25
• Last updated: 2024-09-25