UMIN-CTR Clinical Trial

Basic information
Public title	Tipepidine in children with Autism Spectrum Disorder : a 4-week, open-label, preliminary study
Acronym	Tipepidine in children with Autism Spectrum Disorder
Scientific Title	Tipepidine in children with Autism Spectrum Disorder : a 4-week, open-label, preliminary study
Scientific Title:Acronym	Tipepidine in children with Autism Spectrum Disorder
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Pediatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this research is to confirm the efficacy of the additional medication of the Tipepidine Hibenzate to the youth ASD patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) [Time Frame: Changes from baseline in CY-BOCS at 4-weeks ]
Key secondary outcomes	Repetitive Behavior Scale-Revised(RBS-R), Clinical Global Impression of Change(CGI-C), Vineland Adaptive Behavior Scales Second Edition(Vineland-II) the level of plasma glutamic acid,pro-BDNF,mature-BDNF,MMP-9,oxytocin [Time Frame:Change between baseline scores and 4-weeks]

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Tipepidine Hibenzate (30mg/day, 4weeks)
Interventions/Control_2
Interventions/Control_3
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	6 years-old <=
Age-upper limit	17 years-old >=
Gender	Male and Female
Key inclusion criteria	1.diagnosis of ASD in accordance with the criteria in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) 2.Patients not being treated or taking atypical antipsychotics (risperidone, olanzapine, quetiapine, perospirone, aripiprazole, blonanserin, paliperidone), atomoxetine, methylphenidate, carbamazepine, sodium valproate, gabapentin, topiramate, lamotrigine are eligible 3.The dose of the concomitant drugs has been fixed for at least 4 weeks prior to entry 3.Patients are stable for 4-weeks for medication.
Key exclusion criteria	1.Patients with a previous hypersensitivity to Tipepidine Hibenzate. 2.Patients treated with typical antipsychotics and selective norepinephrine reuptake inhibitor (NRI) except atomoxetine and stimulants except methylphenidate. 3.Pregnant or breast-feeding women
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaomi Iyo
Organization	Chiba University School of Medicine
Division name	Department of Psychiatry
Zip code
Address	1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
TEL	043-222-7171
Email	iyom@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Middle name Last name Ayumi Okato
Organization	Chiba University Hospital
Division name	Department of Child Psychiatry
Zip code
Address	1-8-1 Inohana Chiba, Chuo-ku, Japan, 260-8670
TEL	043-222-7171
Homepage URL
Email	okatoa@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Scholarship Donations
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 24 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	Completed
Date of protocol fixation	2017 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 24 Day
Last modified on	2019 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028707

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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