NCT06312189Enrolling By Invitation3 期
Open-Label Study of Valbenazine for the Treatment of Chorea Associated With Huntington Disease in Canada
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate long-term safety and tolerability of valbenazine in participants with chorea associated with Huntington Disease (HD) who participated in Study NBI-98854-HD3006 (NCT04400331) in Canada.
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
- •Participated in Study NBI-98854-HD3006 and completing dosing through the Week 156 visit; or were actively participating, receiving study treatment, and completed an early termination visit Study NBI-98854-HD3006 at the time of the study closure at sites in Canada.
- •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 medically significant abnormality, physical examination finding, clinically significant laboratory abnormality
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 Week 106
次要结局
未报告次要终点
研究者
研究点 (4)
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