NCT07459647招募中2 期
An Open-Label Study to Assess the Long-Term Safety, Tolerability, and Effectiveness of ML-007C-MA in Adult Participants With Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 42
- 主要终点
- To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ML-007C-MA
Experimental
干预措施: ML-007C-MA (Drug)
结局指标
主要结局
To assess the safety and tolerability of long-term ML-007C-MA administration in adult participants with schizophrenia
时间窗: From initial dose through end of treatment (up to 52 weeks)
using the incidence of TEAEs, TE-SAEs, and TEAEs leading to study discontinuation.
次要结局
未报告次要终点
研究者
研究点 (42)
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