An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)

Официальное название

A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression

Обзор

X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.

Вмешательства

• Препарат Azetukalner
  Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.

Первичные конечные точки

• Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest [Срок оценки: From the start of treatment in the open-label extension study through 8 weeks after the last dose]

Вторичные конечные точки (3)

• Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time [Срок оценки: From baseline through the active extension treatment (Week 52)]
• Change in Clinical Global Impression of Severity (CGI-S) score over time [Срок оценки: From baseline through the active extension treatment (Week 52)]
• Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time [Срок оценки: From baseline through the active extension treatment (Week 52)]

Критерии участия

Критерии включения

• Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression.
• Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
• Participant is willing to comply with the contraception requirements.

Критерии исключения

• Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
• Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
• Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
• Participant is pregnant, breastfeeding, or planning to become pregnant.
• Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for the treatment of any medical condition during the study or within 28 days after completion of this study.
• Participant is judged by the investigator to have a significant risk for self-harm or suicidal behavior during their participation in the study or is considered to be an imminent danger to themself or others.

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

США · 15 центров

• Woodland International Research Group — Little Rock
• Woodland Research Northwest — Rogers
• ProScience Research Group — Culver City
• PharmaSouth Research, LLC — Coral Gables
• Clinical Neuroscience Solutions, Inc. — Jacksonville
• Clinical Neuroscience Solutions — Orlando
• Synexus Clinical Research, Inc. — Atlanta
• CenExel iResearch — Decatur
• … и ещё 7 центров

Идентификаторы

NCT: NCT07217860 · XPF-010-B302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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