An Early Phase II Trial for Efficacy and Safety of TTA-121 on Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
研究概览
简要总结
To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 54 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of autism spectrum disorder based on Diagnostic and Statistical Manual of Mental Disorders-V with score exceeding the cut-off value of 10 for qualitative abnormalities in social reciprocity on Autism Diagnostic Interview Revised (ADIR)
- •Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III
- •Written informed consent for participating the trial
排除标准
- •Diagnosis of bipolar disorder or schizophrenia spectrum disorder
- •Primary diagnosis of depressive disorders, obsessive-compulsive and related disorders, anxiety disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, or neurodevelopmental disorders other than autism spectr um disorder
- •Instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders
- •History of changes in medication or doses of psychotropics within one month before registration
- •Current treatment with more than one psychotropics
- •History of hyper-sensitivity to oxytocin
- •History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes
- •History of alcohol-related disorders, substance abuse, or addiction
- •Family history of male breast cancer
- •Subject who has severe complications
- •Known hypersensitivity to some drugs and foods
- •Subject who is not able to consent contraception during study period
- •Participation in another registration clinical trial and administration of investigational drug during 120 days before informed consent
- •Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study
研究组 & 干预措施
High dose twice per day and placebo
Four weeks administrations of TTA-121 10U twice per day in morning and evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.
干预措施: TTA-121 (Drug)
Low dose once per day and placebo
Four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening.
After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.
干预措施: TTA-121 (Drug)
Low dose twice per day and placebo
Four weeks administrations of TTA-121 3U twice per day in morning and evening. After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.
干预措施: TTA-121 (Drug)
High dose once per day and placebo
Four weeks administrations of TTA-121 10U once per day in morning and placebo once per day in evening.
After four weeks washout, four weeks administrations of placebo twice per day in morning and evening.
干预措施: TTA-121 (Drug)
Placebo and low dose once per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening.
干预措施: TTA-121 (Drug)
Placebo and low dose twice per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 3U twice per day in morning and evening.
干预措施: TTA-121 (Drug)
Placebo and high dose once per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 10U once per day in morning and placebo once per day in evening.
干预措施: TTA-121 (Drug)
Placebo and high dose twice per day
Four weeks administrations of placebo twice per day in morning and evening. After four weeks washout, four weeks administrations of TTA-121 10U twice per day in morning and evening.
干预措施: TTA-121 (Drug)
结局指标
主要结局
Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
时间窗: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Changes in social reciprocity score (range: 0-14, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period
次要结局
- Efficacy on autism spectrum core symptom assessed by communication score on the Autism Diagnostic Observation Schedule module 4(At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration)
- Efficacy assessed by Global Assessment of Functioning(At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration)
- Efficacy assessed by Clinical Global Impression-Severity(At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration)
- Efficacy on autism spectrum core symptom assessed by revised algorithm score of social affect on the Autism Diagnostic Observation Schedule module 4(At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration)
- Efficacy on autism spectrum core symptom assessed by revised algorithm of repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4(At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration)
- Efficacy assessed by Clinical Global Impression-Improvement(At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration)
- Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4(At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration)
- Efficacy assessed by quantitative analysis of facial expression(At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration)
- Efficacy assessed by gaze fixation time on social region(At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 60 min after the last drug administration)
研究者
Hidenori Yamasue, M.D., Ph.D.
Professor
Hamamatsu University