Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

Официальное название

A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia

Обзор

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Вмешательства

• Препарат Xanomeline/Trospium Chloride
  Specified dose on specified days
• Препарат Placebo
  Specified dose on specified days

Первичные конечные точки

• Time From Randomization to the First Relapse Event [Срок оценки: Up to approximately Week 43]

Вторичные конечные точки (6)

• Time to Discontinuation During Double-blind Treatment Period [Срок оценки: Approximately From Week 18 to 43]
• Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately Week 45]
• Number of Participants With Adverse Events of Special Interest (AESIs) [Срок оценки: Up to approximately Week 45]
• Number of Participants With Procholinergic Symptoms [Срок оценки: Up to approximately Week 45]
• Number of Participants With Anticholinergic Symptoms [Срок оценки: Up to approximately Week 45]
• Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to approximately Week 45]

Критерии участия

Критерии включения

• Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
• Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
• Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
• Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:

• Item 1 (P1; delusions)
• Item 2 (P2; conceptual disorganization)
• Item 3 (P3; hallucinatory behavior)
• Item 6 (P6; suspiciousness/persecution)
• Participant must have a CGI-S score of ≥ 4 at screening and Day -1
• Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.

Критерии исключения

• Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
• Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
• Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
• Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
• Participant must not have a history of treatment resistance to schizophrenia medications
• Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
• 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 33 центра

• Local Institution - 0133 — Bentonville
• Local Institution - 0154 — Bentonville
• Local Institution - 0139 — Little Rock
• Local Institution - 0021 — Little Rock
• Local Institution - 0153 — Rogers
• Local Institution - 0190 — Anaheim
• Local Institution - 0040 — Bellflower
• Local Institution - 0188 — Chino
• … и ещё 25 центров

Румыния · 8 центров

• Local Institution - 0103 — Bucharest
• Local Institution - 0105 — Bucharest
• Local Institution - 0107 — Bucharest
• Local Institution - 0110 — Bucharest
• Local Institution - 0174 — Bucharest
• Local Institution - 0106 — Bucharest
• Local Institution - 0109 — Bucharest
• Local Institution - 0055 — Iași

Аргентина · 4 центра

• Local Institution - 0175 — Río Cuarto
• Local Institution - 0143 — Buenos Aires
• Local Institution - 0002 — Córdoba
• Local Institution - 0144 — Santiago del Estero

Дания · 4 центра

• Local Institution - 0159 — Aarhus
• Local Institution - 0182 — Hovedvejen 19
• Local Institution - 0157 — Glostrup
• Local Institution - 0158 — Aalborg

Польша · 4 центра

• Local Institution - 0123 — Warsaw
• Local Institution - 0122 — Bialystok
• Local Institution - 0120 — Gdansk
• Local Institution - 0001 — Poznan

Испания · 4 центра

• Local Institution - 0112 — Barcelona
• Local Institution - 0101 — Barcelona
• Local Institution - 0167 — Valladolid
• Local Institution - 0181 — Zamora

Чехия · 2 центра

• Local Institution - 0162 — Brno
• Local Institution - 0014 — Klecany

Болгария · 1 центр

• Local Institution - 0191 — Novi Iskar

Великобритания · 1 центр

• Local Institution - 0177 — Oxford

Идентификаторы

NCT: NCT07686263 · CN012-0006 · 2025-523664-20 · U1111-1327-7599

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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