NCT03444038已完成2 期
Open-Label Safety and Tolerability Study of Optimized Doses of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 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 2b, multicenter, open-label study to evaluate the safety and tolerability of optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with Tourette Syndrome.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have participated in and completed Study NBI-98854-TS2003
- •Have a clinical diagnosis of Tourette Syndrome (TS)
- •If using maintenance medication(s) for TS or TS spectrum diagnoses (e.g. obsessive-compulsive disorder [OCD], Attention-Deficit Hyperactivity Disorder [ADHD]), be on stable doses
- •Be in good general health
- •Adolescent subjects (12 to 18 years of age) must have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids and a negative alcohol screen
- •Subjects of childbearing potential who do not practice total abstinence 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
排除标准
- •Have an active, clinically significant unstable medical condition within 1 month prior to screening
- •Have a known history of long QT syndrome or cardiac arrhythmia
- •Have a known history of neuroleptic malignant syndrome
- •Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed)
- •Have an allergy, hypersensitivity, or intolerance to vesicular monoamine transporter 2 (VMAT2) inhibitors
- •Have a blood loss ≥250 mL or donated blood within 56 days prior to baseline
- •Have a known history of substance (drug) dependence, or substance or alcohol abuse
- •Have a significant risk of suicidal or violent behavior
- •Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study
研究组 & 干预措施
Valbenazine
Experimental
Valbenazine administered once daily for up to 24 weeks
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: Baseline through Week 24
A TEAE is an adverse event not present prior to the initiation of study drug dosing, or is an already present event that worsens either in intensity or frequency following the initiation of study drug dosing. All qualifying TEAE are reported regardless of threshold.
次要结局
未报告次要终点
研究者
研究点 (1)
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