NCT04400331已完成3 期
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease
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
- 154
- 试验地点
- 35
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide participants continued access to valbenazine for the treatment of chorea associated with Huntington disease.
详细描述
After completion of Week 156/early termination visit, participants in the US will be given the option to continue into an extended maintenance period for up to 104 weeks and participants in Canada will have the option to participate in a separate open-label study (Study NBI-98854-HD3022).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either #1 or #2 must be met for inclusion eligibility.
- •Have participated in Study NBI-98854-HD3005 and
- •a. Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing through the follow-up visit or early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure related to COVID-19)
- •Did not participate in Study NBI-98854-HD3005 and
- •Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea
- •Be able to walk, with or without the assistance of a person or device
- •Be able to read and understand English and capable of providing consent to study participation or have a legally authorized representative providing consent and the participant providing assent
- •Participants of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment
排除标准
- •Have difficulty swallowing
- •Are currently pregnant or breastfeeding
- •Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
- •Have an unstable or serious medical or psychiatric illness
- •Have a significant risk of suicidal behavior
- •Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
- •Have received gene therapy at any time
- •Have received an investigational drug in a clinical study (other than valbenazine) within 30 days before the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
- •Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
- •Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study
- •Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
- •Have a known hypersensitivity to any component of the formulation of valbenazine
- •For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline
研究组 & 干预措施
Valbenazine
Experimental
Capsule, administered orally once daily.
干预措施: Valbenazine (Drug)
结局指标
主要结局
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to 262 weeks
次要结局
- Change from Baseline in the Unified Huntington's Disease Rating Scale (UHDRS) Total Maximal Chorea (TMC) Score(Up to 262 weeks)
研究者
研究点 (35)
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