Идёт набор NCT06929273

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Фаза III С лечением Bipolar Disorder Type I With Mania

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: KarXT, Lithium, Valproate, Lamotrigine.
Кому может быть актуально: Состояния в реестре: Bipolar Disorder Type I With Mania. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Болгария, Китай +15
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Обзор

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Вмешательства

Препарат KarXT
Specified dose on specified days
Препарат Lithium
Therapeutic dose
Препарат Valproate
Therapeutic dose
Препарат Lamotrigine
Therapeutic dose

Первичные конечные точки

Number of participants with treatment emergent adverse events (TEAEs) [Срок оценки: Up to week 54]

Вторичные конечные точки (8)

Number of participants with AEs of special interest (AESIs) [Срок оценки: Up to week 54]
Number of participants with serious AEs (SAEs) [Срок оценки: Up to week 54]
Number of participants with TEAEs leading to treatment discontinuation [Срок оценки: Up to week 52]
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to week 54]
Change from baseline in Barnes Akathisia Rating Scale (BARS) score [Срок оценки: Up to week 54]
Change from baseline in Simpson Angus Scale (SAS) score [Срок оценки: Up to week 54]
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score [Срок оценки: Up to week 54]
Change from baseline in International Prostate Symptom Score (IPSS) [Срок оценки: Up to week 54]

Критерии участия

Критерии включения

Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):

a. Participants must have completed treatment period of parent study.

De novo participants who did not participate in double-blind placebo-controlled studies:

Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.
Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
Participants does not require hospitalization for acute mania.

Критерии исключения

All participants:

1\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.

Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):

1\. Discontinuation from any KarXT parent studies.

De novo participants who did not participate in double-blind placebo-controlled studies:

Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.
Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
Other protocol-defined Inclusion/Exclusion criteria apply.

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