JPRN-UMIN000035172已完成2 期
The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase II trial - Pyridoxamine for ASD trial
Department of Pediatrics,Tohoku University Hospital0 个研究点目标入组 72 人开始时间: 2018年12月8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
- 72
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
- 12years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
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,ADHD therapeutic agent, 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, 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.
研究者
相似试验
已完成
2 期
The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase 2 trialAutism Spectrum DisorderJPRN-jRCT2021200001Kure Shigeo78
已完成
2 期
The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase 2 trialAutism Spectrum DisorderJPRN-jRCT2091220438Department of Pediatrics, Tohoku University Hospital79
招募中
2 期
Pyridoxamine for menopausal disordermenopausal disorder with psychological symptomsJPRN-jRCTs031220256Terauchi Masakazu50
尚未招募
2 期
In patients with cancer receiving medicines this is a study trying reduce vomiting sensationsCTRI/2024/07/071163Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER
已完成
不适用
Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysisEnd-stage renal diseaseJPRN-UMIN000007169Tokai University School of Medicine6