NCT02202213已完成1 期
Interventional, Randomised, Double-blind, Placebo Controlled, Multiple-dose Study Investigating the Safety, Tolerability, PK and PD Properties of Lu AF11167 in Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Lu AF11167 in patients with schizophrenia following various repeated dosing regimens of Lu AF11167 (alone or as added treatment to risperidone).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged ≥18 years and ≤60 years with a body mass index (BMI) of ≥18.5 and ≤38 m2
- •Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
- •Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at the Screening Visit and Baseline Visit (Day -1)
- •PANSS total score ≤80 at the Screening Visit and the Baseline Visit (Day -1)
- •Score of 4 (moderate) of the following PANSS items at the Screening Visit and the Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)
- •Minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A; parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and the Baseline Visit
- •Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit (Day -1)
排除标准
- •The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
- •The patient experienced an acute exacerbation requiring increase in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
- •Other pre-defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Lu AF11167 hard capsules; 0.25, 0.5 and 1 mg
Experimental
Part A: Lu AF11167 monotherapy Part B: Lu AF11167 adjunctive therapy to risperidone
Three times daily oral dosing for 14 days.
干预措施: Lu AF11167 (Drug)
Matching placebo
Placebo Comparator
Daily oral dosing matching the experimental arm.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute values and changes from baseline in safety variables (Adverse events, clinical safety laboratory tests, vital signs,respiratory rate, weight, body temperature and ECG)
时间窗: Screnning to day 25
次要结局
- Columbia Suicide Severity Rating Scale (C-SSRS)(Screening to day 25)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study With Lu AF11167 for the Treatment of Negative Symptoms in Patients With SchizophreniaSchizophreniaNCT03793712H. Lundbeck A/S168
终止
2 期
Flexible-dose Long-term Extension Study of Lu AF11167 in Patients With Schizophrenia With Prominent Negative SymptomsSchizophreniaNCT03929497H. Lundbeck A/S96
终止
1 期
A Study to Evaluate Lu AF90103 in Healthy MenHealthyNCT04940949H. Lundbeck A/S15
终止
1 期
Safety and Tolerability of Lu AF95245 in Healthy Young MenHealthyNCT04199585H. Lundbeck A/S18
已完成
1 期
Lu AF28996 in Participants With Parkinson's Disease (PD)Parkinson DiseaseNCT04291859H. Lundbeck A/S57