A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Orally Administered ML-007C-MA in Inpatient Adult Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 307
- 试验地点
- 25
- 主要终点
- Change From Baseline to End of Treatment in Positive and Negative Syndrome Scale (PANSS) Total Score
研究概览
简要总结
ML-007C-MA-211 is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered ML-007C-MA in inpatient adult participants aged 18 to 64 years with schizophrenia experiencing an acute exacerbation of psychosis.
The primary objective is to evaluate the efficacy of ML-007C-MA compared with placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant 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).
- •Participant may benefit from hospitalization or is currently hospitalized due to an acute exacerbation of schizophrenia symptoms, with exacerbation onset within 2 months of Screening. If the participant is already hospitalized for acute exacerbation of schizophrenia at Screening, they must have been inpatient for less than 2 weeks at the start of Screening.
- •At Screening and Baseline, schizophrenia symptoms are at least moderate in severity and persistent, as defined by the PANSS and CGI-S.
- •Participant is willing and able to be confined to an inpatient setting for the study duration, follow instructions, and adhere to protocol requirements.
排除标准
- •Participant has any DSM-5 disorder, other than schizophrenia, within 12 months before Screening that is primarily responsible for the current symptoms or functional impairment.
- •Participant has any psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before Screening and/or current involuntary hospitalization or incarceration.
- •Participant received any antipsychotic medication or prohibited therapy within the Screening Period unless discontinued before Baseline.
- •Participant has current evidence of a clinically significant and/or unstable medical comorbidity at Screening or Baseline.
- •Participant is at an elevated risk of suicidal behavior.
- •Participant has a known or likely allergy or other intolerance to ML-007C-MA, its active ingredients or their excipients or has a known or likely severe allergic reaction (eg, anaphylactic reaction, angioedema) to any drug that could pose a risk to the participant in this study.
- •Participant 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 International Neuropsychiatric Interview).
- •Participation in a clinical research study involving the administration of an investigational or marketed drug, biological product, or device within 90 days of Baseline, or concomitant active participation in an investigational study involving no drug, biological product, or device. Participants who have previously participated in a study with ML-007 may not participate.
- •Participant is at elevated risk of violent or destructive behavior based on participant history and investigator judgment.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
ML-007C-MA QD
干预措施: ML-007C-MA QD (Drug)
ML-007C-MA BID
干预措施: ML-007C-MA BID (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment in Positive and Negative Syndrome Scale (PANSS) Total Score
时间窗: Baseline and End of Treatment (5 weeks)
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
次要结局
- Change From Baseline to End of Treatment in CGI-S score(Baseline and End of Treatment (5 weeks))
- Change From Baseline to End of Treatment in PANSS-Marder positive factor score(Baseline and End of Treatment (5 weeks))
- Change From Baseline to End of Treatment in PANSS-Marder negative factor score(Baseline and End of Treatment (5 weeks))