JPRN-jRCT2091220438已完成2 期
The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase 2 trial - Pyridoxamine for ASD trial
Department of Pediatrics, Tohoku University Hospital0 个研究点目标入组 79 人开始时间: 2020年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients diagnosed with autism spectrum discrder by DSM-5
- •2. Patients aged 12 years or older at the time of acquisition
- •3. Patients who have consented to participate in clinical trials from principal and substitute in the document (If the age at the time of consent acquisition is under 20 years old, consent of participation in clinical trial is obtaind from the substitute,regardless of ages, if the patient does not have the ability of agreement, written consent is obtaind from the substitute), and the patient who can visit the outpatient clinic with guardian at the designated time, a designated number of times
- •4. Patients who scored 18 or more excitatory subscale scores of Abnormal Behavior Checklist Japanese Version (ABC-J)
排除标准
- •1.Patients with a history of hypersensitivity to vitamin B6
- •2.Patients diagnosed with schizophrenia
- •3.Patient who is diagnosed with bipolar I disorder, bipolar II disorder, depression / major depressive disorder, and undergoing oral treatment for treatment
- •4. Patients with severe liver disease or liver injury (AST or ALT> 3 times the upper limit of the facility reference value) at screening
- •5.Patients with severe heart disease
- •6.Patients with impaired renal function (creatinine value> 2.0 mg / dL) at screening
- •7.Patients with gastrointestinal disorders, respiratory disorders, hematological disorders, endocrine disorders, immune disorders or other systemic disorders
- •8.In case of epilepsy complications, patients who had a epileptic seizure during the last 6 months until subject screening
- •9. At the beginning of study medication administration, patients using either of the following; vitamin B6, typical antipsychotics, anxiolytics, antihistamine drugs, etc.
- •10.During the trial period, patients using two or more sleep inducer
- •11.Patients who can not agree that the dosage regimen of the drugs shown below is in principle unchangeable during the trial period. Patients who do not agree to discontinue taking as needed or to take at a fixed dose when using consent at the time of taking medicine; atypical antipsychotics, sleep inducer, antiepileptic drugs, ADHD therapeutic agent, etc
- •12.Patients with malignant tumor coexisting at the time of subject screening or undergoing surgery for malignant tumor within 5 years before subject screening
- •13.Patient who wishes to become pregnant during pregnancy or lactation when subject screening
- •14.Patients participating in other trials or clinical studies at registration
- •15.Because of self-injurious behavior, suicidal ideation or other symptoms, the investigator or clinical trial doctor consider as high risks such as poor treatment compliance, failure to complete the trial, obstructing participation in the trial, affecting safety, etc.
- •16. Patients judged by Principal Investigator or Sub-investigator to be inappropriate for other reasons
研究者
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