The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase 2 trial

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 79

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amounts of change from excitatory subscale from baseline of Abnormal Behavior Checklist Japanese Version(ABC-J)

Secondary Outcome Measures

Name	Time	Method
ABC-J total score and other sub scale score change from baseline, Response rate, Sensory profile, repeat behavior scal, Hyperacusis Questionnaire, clinical global impression-improvement, sensory investigation and symptom change questionnaire.

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