A Long-Term Open-Label Study of ML-007C-MA in Adults With Schizophrenia

Официальное название

An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia

Обзор

ML-007C-MA-212 is a 52-week open-label study designed to evaluate the long-term safety, tolerability, and effectiveness of ML-007C-MA in participants with schizophrenia who have recently completed an antecedent study (ML-007C-MA-211) or enroll directly (De Novo Cohort).

Вмешательства

• Препарат ML-007C-MA
  ML-007C-MA dosed as 210/3 mg BID

Первичные конечные точки

• To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia [Срок оценки: From initial dose through end of treatment (up to 52 weeks)]

Критерии участия

Критерии включения

• Must be able and willing to provide informed consent for all required study procedures.
• Has a primary diagnosis of schizophrenia based on the DSM-5 criteria that is confirmed by semi-structured clinical interview (Mini International Neuropsychiatric Interview for DSM-5).
• May benefit from long-term pharmacotherapy for schizophrenia, based on assessment of the investigator.
• Is appropriate for an outpatient level of care and resides in a stable living situation, based on assessment of the investigator.
• Has an identified reliable informant(s) available to participate in relevant assessments. Site staff may serve as the informant if the site has had regular contact with the participant for >1 year.

Критерии исключения

• Has any DSM-5 disorder, other than schizophrenia, within the 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
• Is discontinuing effective and well-tolerated antipsychotic therapy for the purpose of enrolling in this study.
• Has received any prohibited therapy within the Screening Period unless discontinued before Baseline.
• Has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
• Has clinically significant abnormal physical examination, ECG, or clinical safety laboratory result at Screening or Baseline.
• Has an elevated risk of suicidal behavior.
• Has a known allergy to ML-007C-MA, its active ingredients or their excipients.
• Has a DSM-5 diagnosis of moderate to severe substance use disorder (except tobacco or caffeine use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening).
• Has an elevated risk of violent or destructive behavior, based on participant history and investigator judgment.

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 · 5 центров

• Clinical Site — Lemon Grove
• Clinical Site — Miami Lakes
• Clinical Site — Chicago
• Clinical Site — Staten Island
• Clinical Site — DeSoto

Идентификаторы

NCT: NCT07459647 · ML-007C-MA-212

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗