UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035172 |
|---|---|
| Receipt number | R000040082 |
| Scientific Title | The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase II trial |
| Date of disclosure of the study information | 2018/12/08 |
| Last modified on | 2021/06/10 19:13:40 |
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Basic information
Public title
The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase II trial
Acronym
Pyridoxamine for ASD trial
Scientific Title
The efficacy and safety of pyridoxamine in patients with autism spectrum disorder; Exploratory physician-led Phase II trial
Scientific Title:Acronym
Pyridoxamine for ASD trial
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Pediatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploritively evaluate the efficacy and safety of pyridoxamine for patients with autism spectrum disorder and determine the appropriate target patient population, dosage regimen, and evaluation index
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Amount of change from excitatory subscale score from baseline of Abnormal Behavior Checklist Japanese Version (ABC-J)
Key secondary outcomes
*ABC-J total score, other subscale score change from baseline
*Sensory profile, repeat behavior scale, Hyperacusis Questionnaire, clinical global impression - improvement, sensory investigation and symptom change questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo
Interventions/Control_2
Oral doses of low dose pyridoxamine divided into twice a day for 8 weeks
12-19 year;800mg
20 years or older;1200mg
Interventions/Control_3
Oral doses of high dose pyridoxamine divided into twice a day for 8 weeks
12-19 years;1200mg
20 years or older;2000mg
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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)
Key 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,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.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Kure |
Organization
Tohoku University Hospital
Division name
Department of Pediatrics
Zip code
9808574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken Japan
TEL
022-717-7287
kure@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hanai |
| Middle name | |
| Last name | Takuto |
Organization
C-55 Clinical trial coordinating office
Division name
Clinical Research Innovation and Education Center
Zip code
9808574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken Japan
TEL
022-717-7136
Homepage URL
c55chiken@crieto.hosp.tohoku.ac.jp
Sponsor or person
Institute
Department of Pediatrics,Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non
Address
Non
Tel
Non
Non
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院（宮城県）、自治医科大学附属病院（栃木県）、国立成育医療研究センター（東京都）、大阪市立総合医療センター（大阪府）、神戸大学医学部付属病院（兵庫県）、宮城県立こども病院（宮城県）、弘前大学病院精神科（青森県）、山形大学医学部付属病院（山形市）、国立精神・神経医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040082
