NCT07365462招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1065890 in Adult Participants With Tardive Dyskinesia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of NBI-1065890 compared with placebo for the treatment of tardive dyskinesia (TD) in adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Medically confirmed diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least 3 months prior to screening.
- •Medically confirmed diagnosis of neuroleptic-induced TD as defined in the DSM-5 for at least 3 months prior to screening.
- •Moderate or severe TD (AIMS Item 8, severity of abnormal movement overall) as assessed by a blinded, external AIMS video reviewer using a video recording of the participant's AIMS assessment administered at the clinical site by a blinded, certified site AIMS rater. The AIMS dyskinesia total score (sum of Items 1 to 7) must be ≥6 as assessed by the blinded, external AIMS video reviewer.
排除标准
- •Comorbid parkinsonism (drug-induced or otherwise) or more than a minimal level of extrapyramidal signs/symptoms, as documented by a score on the Modified Simpson-Angus Scale (mSAS) (excluding Items 8 and 10) >6 at screening or Day -1 (baseline) or a score >3 in any one item (excluding Items 8 and 10).
- •Barnes Akathisia Rating Scale (BARS) global clinical assessment score ≥2 at screening or Day -
- •Brief Psychiatric Rating Scale (BPRS) total score ≥50 at screening or Day -
- •Hospitalized for schizophrenia, schizoaffective disorder, bipolar disorder, or MDD within 6 months of screening.
- •Participant has an unstable medical condition or unstable chronic disease.
- •Any known history of neuroleptic malignant syndrome (NMS).
- •Note: Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo matching NBI-1065890.
干预措施: Placebo (Drug)
NBI-1065890
Experimental
Participants will receive NBI-1065890.
干预措施: NBI-1065890 (Drug)
结局指标
主要结局
Change from Baseline in the Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score at Week 8 Based on the Blinded Central AIMS Video Raters' Assessment
时间窗: Baseline and Week 8
次要结局
- Percentage of Participants Who Are a Clinical Global Impression - Improvement (CGI-I) Responder 1 at Week 8(Week 8)
研究者
研究点 (18)
Loading locations...
相似试验
招募中
2 期
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current ManiaManiaBipolar I DisorderNCT07288320Neurocrine Biosciences150
招募中
3 期
Study to assess the efficacy and safety of adjunctive NBI-1065845 in adults with Major Depressive Disorder (MDD)Major Depressive Disorder2024-519421-37-00Neurocrine Biosciences Inc.55
招募中
2 期
Evaluation of NBI-1117570 in Inpatient Adults With SchizophreniaSchizophreniaNCT07288333Neurocrine Biosciences120
招募中
2 期
A study in people with systemic sclerosis to test whether BI 685509 has an effect on lung function and other systemic sclerosis symptomssystemic sclerosis2022-500332-11-00Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim RCV GmbH & Co. KG68
招募中
3 期
The AIRTIVITY® Study: A study to find out whether BI 1291583 helps people with bronchiectasisBronchiectasis2024-518589-29-00Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.433