NCT07105111招募中4 期
A Phase 4, Open-Label Study to Evaluate the Efficacy of Valbenazine on Clinician- and Patient-Reported Outcomes in Patients With Tardive Dyskinesia (TD) Who Remain Symptomatic While on Deutetrabenazine or After Discontinuing Prior TD Treatment With a Vesicular Monoamine Transporter 2 (VMAT2) Inhibitor
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 23
- 主要终点
- Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24
研究概览
简要总结
This study will evaluate the efficacy of valbenazine on clinician- and patient-reported outcomes in participants with TD while receiving or after stopping a VMAT2 inhibitor.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Diagnosed with one of the following at least 3 months prior to screening: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
- •Diagnosed with at least mild neuroleptic-induced TD for at least 3 months prior to screening
排除标准
- •Have comorbid Parkinsonism or abnormal involuntary movement(s) that is more prominent than TD
- •Diagnosis of moderate or severe substance use disorder in the last 6 months
- •History of long QT syndrome, cardiac arrythmia, or severe hepatic impairment
研究组 & 干预措施
Valbenazine
Experimental
Valbenazine administered once daily for 24 weeks.
干预措施: Valbenazine (Drug)
结局指标
主要结局
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score (AIMS 1-7) at Week 24
时间窗: Baseline, Week 24
次要结局
- Change from Baseline in the Clinical Global Impression of Severity - Tardive Dyskinesia (CGI-TD-S) Score at Week 24(Baseline, Week 24)
- Change from Baseline in the Tardive Dyskinesia Impact Scale (TDIS) at Week 24(Baseline, Week 24)
- Change from Baseline in the EuroQol-Visual Analogue Scale (EQ-VAS) at Week 24(Baseline, Week 24)
研究者
研究点 (23)
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