EUCTR2017-004378-32-ES进行中（未招募）1 期
A phase III, randomized, double-blind, placebo-controlled, efficacy, and safety study of Balovaptan in adults with Autism Spectrum Disorder with a 2 year open-label extension.
Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTD0 个研究点目标入组 322 人开始时间: 2018年5月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 322
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Males or females, age 18 years or older
- •- Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Version 5 (DSM-5) criteria for ASD for an autism diagnosis and is confirmed using Autism Diagnostic Observation Schedule (ADOS)-2 criteria
- •- Social Responsiveness Scale (SRS)-2, proxy version, total t score >=66 at screening
- •- A full scale IQ score >=70 on the Wechsler Abbreviated Scale of Intelligence®-II
- •- Ability and willingness to fully comply with study visit schedule and regular assessments and fluency in the language of the site
- •- Subject’s participation in the study or discontinuation of prohibited medication will not pose undue risks to the subject, in the investigator’s opinion
- •- Subject has an appropriate study partner, in the opinion of the investigator
- •- For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 30 days after the last dose of study drug
- •- Treatment with permitted medications and behavioral therapy regimens, with the intent that such treatments remain stable throughout the study and with no expected changes before the Week 24 visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 349
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •General Exclusion Criteria
- •- Pregnancy or breastfeeding, or intention to become pregnant during the study
- •Neurologic and Psychiatric Exclusion Criteria
- •-Previous initiation of new or major change in psychosocial intervention within 6 weeks prior to screening
- •- Unstable or uncontrolled clinically significant affective or psychotic disorders and/or neurologic disorder that may interfere with the assessment of safety or efficacy endpoints
- •- Alcohol or substance abuse or dependence disorder during the last 12 months, as defined using the DSM-5 criteria
- •- Significant risk for suicidal behavior, in the opinion of the investigator
- •- Epilepsy or seizure disorder considered not well controlled within the past 6 months or changes in anticonvulsive therapy within the last 6 months
- •- Clinical diagnosis of peripheral neuropathy
- •Exclusions Related to Cardiovascular Disorders
- •- Within the last 2 years, unstable or clinically significant cardiovascular disease
- •- Uncontrolled hypertension
- •Exclusions Related to Other Organ Systems
- •- Positive serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) 1 or 2
- •- History of coagulopathies, bleeding disorders, blood dyscrasias, hematological malignancies, myelosuppression, or current major bleeding event
- •- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or what would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- •- Confirmed clinically significant abnormality in parameters of hematology, clinical chemistry, coagulation, or urinalysis
- •- Medical history of malignancy, if not considered cured
- •Additional Exclusion Criteria
- •- Allowed medications have not been stable for 12 weeks prior to screening
- •- Previous treatment with prohibited medications or herbal remedies within 2 weeks prior to randomization or 5 half-lives
- •- Blood donation or loss of blood > 500 mL within 3 months prior to randomization
- •- Previous participation in an investigational drug or device study within 60 days prior to randomization or previous enrollment in investigational trials of balovaptan
研究者
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