A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness of Valbenazine on Patient- and Clinician-Reported Outcomes in Subjects With Tardive Dyskinesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 18
- 主要终点
- Change From Baseline in the Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24
研究概览
简要总结
This study will evaluate the effectiveness of valbenazine on patient- and clinician-reported outcomes assessing health-related quality of life, functioning, and treatment effect in participants with tardive dyskinesia (TD) who are receiving valbenazine for up to 24 weeks.
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
- •At least 18 years of age
- •Have one of the following clinical diagnoses: schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder
- •Have a clinical diagnosis of neuroleptic-induced TD
- •Medication(s) for schizophrenia or schizoaffective disorder, bipolar disorder, or major depressive disorder and other protocol-allowed concurrent medications must be at a stable dose and expected to remain stable during the study
- •Participants must be outpatients and have a stable psychiatric status
排除标准
- •Have comorbid abnormal involuntary movement(s) (for example, Parkinsonism, akathisia) that is more prominent than TD
- •Have an active, clinically significant unstable medical condition in the judgement of the investigator, or have any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit
研究组 & 干预措施
Valbenazine
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 Tardive Dyskinesia Impact Scale (TDIS) Total Score at Week 24
时间窗: Baseline, Week 24
The TDIS assesses the impact of impairment and disability associated with dyskinesia. It defines impact of tardive dyskinesia (TD) in terms of 6 scales: Mouth/Throat Function (3 items), Dexterity (2 items), Mobility (2 items), Pain (1 item), Emotional (2 items), and Social (1 item). Each item measured the impact of dyskinetic movements in terms of difficulty or frequency over the last 7 days on a 5-point scale, with scores ranging from 0 to 4. Response options for the difficulty items ranged from not at all (0) to extremely (4); those for the frequency items ranged from never (0) to all of the time (4). The TDIS total score was the sum of the scores of TDIS Items 1 to 11. Total scores ranged from 0 to 44, with higher scores representing greater TD impact.
Change From Baseline in the Sheehan Disability Scale (SDS) Items 1, 2, and 3 Score at Week 24
时间窗: Baseline, Week 24
The SDS included 3 self-rated items designed to measure how work, social life, and family life are impaired by current psychiatric symptoms. Each item includes an 11-point analog scale that uses visual-spatial, numeric, and verbal descriptive anchors to represent the degree of disruption from 0 (none at all) to 10 (extremely). Participants who had not worked for pay or attended school in the previous 7 days for reasons unrelated to TD did not respond to Item 1 and were therefore excluded from the analysis of that item.
Change From Baseline in the Euro Quality of Life Visual Analogue Scale (EQ-VAS) Score at Week 24
时间窗: Baseline, Week 24
Participants rated their overall health on a 0 to 100 hash-marked, vertical EQ-VAS where 0 represents 'The worst health you can imagine' and 100 represents 'The best health you can imagine.' An increase from baseline indicates an increase in overall health.
次要结局
- Patient Global Impression of Change (PGI-C) Score at Week 24(Week 24)
- 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 Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 24(Baseline, Week 24)