UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028350 |
|---|---|
| Receipt number | 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 11:08:22 |
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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
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
okatoa@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028707
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| Registered date | File name |
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| Registered date | File name |
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