Open-Label Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 主要终点
- Number of Participants Monitored for Long-term Safety of Valbenazine
研究概览
简要总结
This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
详细描述
This study was terminated after 60 weeks due to the commercial availability of valbenazine.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
- •Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.
- •If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.
- •Be in general good health.
- •Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
排除标准
- •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 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 valbenazine) 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.
研究组 & 干预措施
Valbenazine
Fixed dose of valbenazine administered once daily for up to 72 weeks
干预措施: Valbenazine (Drug)
结局指标
主要结局
Number of Participants Monitored for Long-term Safety of Valbenazine
时间窗: 60 weeks
Incidence of adverse events and monitoring of vital signs, clinical laboratory values, and electrocardiograms. All AEs were coded into preferred terms according to MedDRA (Medical Dictionary for Regulatory Activities) and classified by system organ class (SOC). Summaries of the incidence of all treatment-emergent AEs, treatment-related AEs, SAEs, and AEs leading to study drug discontinuation were prepared.
次要结局
- Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale(Baseline and Weeks 12, 24, 36, 48, and 60)
- Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)(Baseline and Weeks 12, 24, 36, 48, and 60)