NCT02405091已完成3 期
A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 167
- 主要终点
- Number of Participants Monitored for Long-Term Safety of Valbenazine
研究概览
简要总结
Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study.
- •Female subjects must not be pregnant.
- •Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder
- •Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
- •Have moderate or severe TD
- •If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
- •Be in general good health.
- •Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
- •Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids.
- •Exclusion Criteria
- •Have an active, clinically significant unstable medical condition within 1 month prior to screening.
- •Have a known history of substance dependence, substance (drug) or alcohol abuse.
- •Have a significant risk of suicidal or violent behavior.
- •Have a known history of neuroleptic malignant syndrome.
- •Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
- •Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
- •Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
- •Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
- •Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
- •Are currently pregnant or breastfeeding.
排除标准
- 未提供
研究组 & 干预措施
Dose Group 1
Experimental
Fixed dose of NBI-98854 administered once daily for 48 weeks
干预措施: NBI-98854 (Drug)
Dose Group 2
Experimental
Fixed dose of NBI-98854 administered once daily up to 48 weeks
干预措施: NBI-98854 (Drug)
结局指标
主要结局
Number of Participants Monitored for Long-Term Safety of Valbenazine
时间窗: 52 weeks
Number of participants monitored for long-term safety through reporting of treatment-emergent adverse events and monitoring of vital signs, clinical laboratory values, and ECG. Summaries of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
次要结局
- Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 48; On-site AIMS Raters(Baseline and Week 48)
- Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; On-Site AIMS Raters(Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52)
- Severity of Tardive Dyskinesia (TD) Symptoms Assessed by Abnormal Involuntary Movements Scale (AIMS) Dyskinesia Total Score Change From Baseline; Central AIMS Video Raters(Baseline, Change from Baseline at Week 8, and Change from Baseline at Week 52)
- Clinical Global Impression - Global Improvement of Tardive Dyskinesia (CGI-TD) at Week 48(Week 48)
研究者
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