NCT05654870终止3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10
研究概览
简要总结
This primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medically confirmed diagnosis of schizophrenia
- •Participant is receiving a stable regimen of background antipsychotic medication
- •Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay
- •Participant is an outpatient with stable symptomatology
- •Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse)
排除标准
- •Has a history of treatment resistant schizophrenia
- •Have a clinically significant unstable medical condition in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
- •Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors
研究组 & 干预措施
Valbenazine
Experimental
Valbenazine once daily
干预措施: Valbenazine (Drug)
Placebo
Placebo Comparator
Placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10
时间窗: Baseline, Week 10
次要结局
- Change in Personal and Social Performance (PSP) Score from Baseline to Week 10(Baseline, Week 10)
- Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10(Baseline, Week 10)
研究者
研究点 (1)
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