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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Autism Spectrum Disorder | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |