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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name