A Phase III, 12-week, Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Determine the Efficacy, Safety, and Tolerability of a Dose of 15 mg Bid of Evenamide as add-on in Patients With Documented Treatment-resistant Schizophrenia, Which is Not Adequately Controlled by a Stable Therapeutic Dose of the Patient's Current Antipsychotic Medication(s)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 23
- 主要终点
- Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
研究概览
简要总结
This is a prospective, 12-week, randomized, double-blind, placebo-controlled study, designed to evaluate the efficacy, safety, and tolerability of a dose of evenamide of 15 mg bid, compared to placebo, as add-on treatment in patients with documented treatment-resistant schizophrenia (TRS) who have prospectively demonstrated inadequate response to their current stable therapeutic dose of an antipsychotic(s). Approximately 400 patients will be randomized equally (1:1) to each of the two treatment groups in this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - 18 years, or older.
- •If female, the subject has a negative pregnancy test at the screening visit and at baseline, is not lactating, and agrees to use adequate contraception, unless not of childbearing potential.
- •Meets current DSM-5-TR criteria for schizophrenia.
- •Has shown treatment-resistance to antipsychotics as per TRRIP working group definition (Howes et al., 2017).
- •Currently receiving "standard of care" therapy of a minimal recommended therapeutic dose of one or more antipsychotic(s).
- •Has a Clinical Global Impression - Severity of disease (CGI-S) rating of "mildly ill" to "among the most extremly ill" at baseline.
- •Has a BPRS total score ≥ 45 at screening and baseline.
- •Has a PANSS total score ≥ 70 at baseline.
- •Has a Global Assessment of Functioning (GAF) scale total score ≤
- •Adherence to prescribed antipsychotic treatment.
- •Patient has provided written informed consent prior to participating in the study.
排除标准
- •Current DSM-5-TR diagnosis of schizophreniform disorder, schizoaffective disorder, or other primary psychiatric diagnosis, such as bipolar disorder or major depressive disorder
- •History (within three months of study entry) or current diagnosis of "Substance Use Disorder" as defined by the DSM-5-TR criteria.
- •Severity of current episode of psychosis requires that the patient be hospitalized to stabilize the severity of his/her psychotic symptoms. However, these patients may qualify for the study provided their antipsychotic dose has been stable for 6 weeks prior to screening.
- •History or current diagnosis of other psychiatric or behavioral disorders.
- •Known suicidal risk, or a suicide attempt within the past 2 years.
- •History of neuroleptic malignant syndrome or priapism.
- •Disease/medical condition of any type that may impact the patient's safety or interfere with any of the study evaluations.
- •History or current diagnosis of epilepsy or seizure disorder, or occurrence of a seizure within the past year, or repeated drug-induced seizures.
研究组 & 干预措施
Evenamide 15 mg bid
Evenamide capsules 15 mg bid for a total of 12 weeks of add-on treatment
干预措施: Evenamide 15 mg bid (Drug)
Placebo
Matching placebo capsules bid for a total of 12 weeks of add-on treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline to endpoint (Week 12) on the total score of the Positive and Negative Syndrome Scale (PANSS).
时间窗: From Baseline to Week 12
Efficacy measured by the mean change from baseline to endpoint of Positive and Negative Syndrome Scale \[PANSS\] total score: a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
Incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
时间窗: From Baseline to 30-day Safety Follow up (12 Weeks of treament + 30-day safety follow up)
Safety and tolerability of a dose of evenamide of 15 mg bid, compared to placebo. The assessment of safety and tolerability will be based primarily on the incidence of treatment-emergent adverse events (TEAEs), AEs leading to discontinuation (ADOs), and serious AEs (SAEs).
次要结局
- Change from baseline to endpoint (Week 12) on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form scale (Q-LES-Q-SF).(From Baseline to Week 12)
- Proportion of patients rated as 'improved' on the CGI-C at endpoint (Week 12).(Week 12)
- Change from baseline to endpoint (Week 12) on the Clinical Global Impression - Severity of illness (CGI-S) score.(From Baseline to Week 12)
- Change from baseline to endpoint (Week 12) on the Personal and Social Performance (PSP) scale.(From Baseline to Week 12)
- Change from baseline to endpoint (Week 12) on the Positive Symptoms sub-scale score of the PANSS.(From Baseline to Week 12)