2022-502233-25-00已完成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
Neurocrine Biosciences Inc., Neurocrine Biosciences Inc.32 个研究点 分布在 6 个国家目标入组 199 人开始时间: 2023年6月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 32
- 主要终点
- Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]
研究概览
简要总结
The primary objective for this study is to evaluate the efficacy of adjunctive valbenazine versus placebo on symptoms of schizophrenia in subjects who have inadequate response to antipsychotic treatment
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]
次要结局
- Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]
- Change in Personal and Social Performance (PSP) Score from Baseline to Week 10 [Time Frame: Baseline, Week 10]
研究者
Neurocrine Medical Information Call Center
Scientific
Neurocrine Biosciences Inc.
研究点 (32)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with SchizophreniaSchizophrenia2023-508433-14-00Neurocrine Biosciences Inc.192
进行中（未招募）
2 期
Taldefgrobep Alfa in Adults With Overweight and ObesityObesityNCT07281495Biohaven Therapeutics Ltd.150
招募中
2 期
A Study to Evaluate 9MW1911 in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT07292714Mabwell (Shanghai) Bioscience Co., Ltd.360
招募中
3 期
Study of Oral Deucrictibant XR Tablet for Prophylaxis and Deucrictibant IR Capsule for On-Demand Treatment of Angioedema Attacks in Adults With Acquired Angioedema Due to C1 Inhibitor DeficiencyNCT07266805Pharvaris Netherlands B.V.32
进行中（未招募）
3 期
Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic RhinitisNCT07291284Longbio Pharma546