A Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of CB03-154 as Adjunctive Therapy in Focal Epilepsy (NCT06612775)

The purpose of this study is to test multiple doses of the study drug to see how CB03- 154 works, when compared to placebo, in controlling focal seizure frequency in adults with focal epilepsy who are already taking 1 to 3 antiepileptic drugs (AEDs), and to assess the safety and tolerability of CB03-154 in adults with focal epilepsy. In addition, this study will help determine how the study drug is processed by the body and will measure the effect of the study drug compared to placebo and in addition to standard of care treatment. The study involves approximately 168 patients who will be divided into four groups in a blinded and randomized manner. Each group will receive either one of three different doses of the investigational drug CB03-154 (20 mg, 10 mg, or 5 mg) or a placebo. The assignment to these groups will be completely random and both participant and the study team will not know which treatment they are receiving. The duration of the study is approximately 22 weeks: screening/Baseline least 8 weeks, double-blind treatment period of 12 weeks, and post-treatment follow-up period of 2 weeks (+7 days) after last dose.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

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).