The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase II trial
- Conditions
- Autism spectrum disorder
- Registration Number
- JPRN-UMIN000035172
- Lead Sponsor
- Department of Pediatrics,Tohoku University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 72
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method