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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028350
Receipt No. R000028707
Scientific Title Tipepidine in children with Autism Spectrum Disorder : a 4-week, open-label, preliminary study
Date of disclosure of the study information 2017/07/24
Last modified on 2019/02/27

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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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