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

ConditionFocal Epilepsy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Zhimeng Biopharma, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. The subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • CB03-154

    Drug

    All enrolled subjects will begin with a two-week course of CB03-154 at 10 mg QD. Upon demonstrating good tolerability, the dose will be increased to 20 mg QD and continued for up to two years.

Treatment groups

144 Participants
are divided into 1 treatment group
Group A: The Subjects from CB03-154-EP201Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the long-term tolerability and safety of CB03-154 in patients diagnosed with epilepsy.

Severity and frequency of associated AEs/serious adverse events (SAEs)

Time frame
In the entire period of the whole study, including a treatment period up to 2 years (104 weeks) and a post treatment follow-up period of 8 weeks.
2

To assess the long-term efficacy of CB03-154 in patients diagnosed with epilepsy.

Median percent change (MPC) in monthly (28 days) seizure frequency from baseline (the end of the DBP of study CB03 154-EP201) to the entire treatment period.

Time frame
In the entire period of the whole study, including a treatment period up to 2 years (104 weeks) and a post treatment follow-up period of 8 weeks.

Secondary outcomes

1

Maximum Plasma Concentration (Cmax).

For all subjects, blood samples will be obtained at Week 2, Week 4, Week 13, and Week 26 for in the period of study for plasma concentration measurement.

Time frame
In the Week 2±3 days , Week 4±3 days , Week 13±3 days , and Week 26±7 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhimeng Biopharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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