NCT03265119已完成2 期
A Multicenter, 2-Part, 6-Week, Double-blind, Randomized, Placebo-controlled, Parallel-design Study to Assess the Efficacy and Safety of AEVI-001 in Children and Adolescents (Ages 6-17 Years) With Attention Deficit Hyperactivity Disorder and With or Without Copy Number Variants in Specific Genes Implicated in Glutamatergic Signaling and Neuronal Connectivity
Aevi Genomic Medicine, LLC, a Cerecor company1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年8月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score
研究概览
简要总结
This is PART A of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and neuronal activity. Parts A will include subjects determined to have a specific gene mutations implicated in glutamatergic signaling and neuronal connectivity.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and parent/legally authorized representative (LAR) can speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
- •Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit (Visit 1).
- •Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements prior to administration of investigational product (IP).
- •Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based upon DSM 5 criteria.
- •Subject has a minimum score of ≥28 on the ADHD-RS-5 at the Baseline Visit (Visit 2).
- •Subject has been genotyped previously and has their identity confirmed (if required).
排除标准
- •Subject or parent/LAR is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit (Visit 1) which could interfere with the conduct of study evaluations.
- •Subject has a current, controlled or uncontrolled, co-morbid major psychiatric diagnosis (aside from ADHD), including an anxiety disorder, major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability. Mild anxiety and/or depressive symptoms that do not meet diagnostic criteria for an anxiety disorder or major depression and/or do not require treatment are not exclusionary.
- •Subject has autism spectrum disorder to include a DSM-IV diagnosis of autistic disorder, Asperger's disorder, or pervasive developmental disorder.
- •Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
- •Subject has a known history of cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, or other serious cardiac problems.
- •Subject has any clinically significant abnormality on 12-lead ECG performed at the Screening Visit (Visit 1) and/or the Baseline Visit (Visit 2) such as serious arrhythmia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
研究组 & 干预措施
AEVI-001
Experimental
干预措施: AEVI-001 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale, Version 5 (ADHD-RS-5) Total Score
时间窗: Baseline to Visit 8 (Week 6)
The ADHD-RS-5 is comprised of 18 frequency items and 12 impairment items. Each frequency item was scored on a scale from 0 = "Never or rarely" to 3 = "Very often". The ADHD-RS-5 total score was calculated as the sum of the 18 frequency item scores. The total score ranges from 0 to 54. Higher scores indicate greater symptom severity. Change from baseline value were calculated as the assessment value minus the baseline value.
次要结局
- Clinical Global Impression - Global Improvement (CGI -I) Response(Visit 8 (Week 6))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
PART B: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and Without mGluR MutationsAttention Deficit Hyperactivity DisorderNCT03609619Aevi Genomic Medicine, LLC, a Cerecor company109
已完成
2 期
Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum DisorderNCT05523895ACADIA Pharmaceuticals Inc.237
招募中
3 期
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric PatientsBipolar DepressionNCT06372964Intra-Cellular Therapies, Inc.384
招募中
不适用
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With ColicColic, InfantileNCT05512234BioGaia AB102
招募中
3 期
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric PatientsIrritability Associated With Autism Spectrum DisorderNCT06690398Intra-Cellular Therapies, Inc.160