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

Официальное название

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of CB03-154 in Subjects Diagnosed With Epilepsy

Обзор

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

Подробное описание

This is an open-label extension study based on the Phase 2 clinical trial CB03-154-EP201. The study aims to assess the long-term safety, tolerability, efficacy, and pharmacokinetics (PK) of CB03-154 at a maximum dose of 20 mg administered orally once daily (QD) in patients with epilepsy. Eligible subjects are those who successfully completed the prior CB03-154-EP201 study without early discontinuation. The treatment in this extension study will last for up to two years.

Вмешательства

• Препарат CB03-154
  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.

Первичные конечные точки

• To assess the long-term tolerability and safety of CB03-154 in patients diagnosed with epilepsy. [Срок оценки: 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.]
• To assess the long-term efficacy of CB03-154 in patients diagnosed with epilepsy. [Срок оценки: 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.]

Вторичные конечные точки (1)

• Maximum Plasma Concentration (Cmax). [Срок оценки: In the Week 2±3 days , Week 4±3 days , Week 13±3 days , and Week 26±7 days.]

Критерии участия

Критерии включения

• 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.

2\. Subject must have successfully completed the DBP and have not terminated early from Study CB03-154-EP201, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study, and judged to be efficacious based on the blinded data review (in the opinion of the investigator).

3\. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements.

4\. Subject is able to keep accurate seizure diaries.

Критерии исключения

\- 1. Subject met any of the withdrawal criteria while in Study CB03-154-EP201. 2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study CB03-154-EP201) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol.

3\. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy during the study and until 28 days after completion of this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Alfred Health — Melbourne

Идентификаторы

NCT: NCT07238868 · CB03-154-EP202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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