UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031412 |
|---|---|
| Receipt number | R000035729 |
| Scientific Title | An early phase II trial for efficacy and safety of TTA-121 on autism spectrum disorder |
| Date of disclosure of the study information | 2018/02/27 |
| Last modified on | 2022/08/27 09:04:38 |
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Basic information
Public title
An early phase II trial for efficacy and safety of TTA-121 on autism spectrum disorder
Acronym
An early phase II trial of TTA-121 on autism spectrum disorder
Scientific Title
An early phase II trial for efficacy and safety of TTA-121 on autism spectrum disorder
Scientific Title:Acronym
An early phase II trial of TTA-121 on autism spectrum disorder
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder
To compare effect sizes of different doses
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The primary outcome is changes in ADOS reciprocity between just before and after each administration period.
Key secondary outcomes
ADOS communication and repetitive and restricted behavior, revised algorithm of social affect, and revised algorithm of repetitive and restricted behavior.
Quantitative behavioral indices reflecting social deficits including gaze fixation time on social region during being talked and quantitative analysis of facial expression on videos recorded during ADOS administration.
Clinical Global Impression, General Assessment of Functioning.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening
After four weeks washout, four weeks administrations of placebo twice per day in morning and evening
Interventions/Control_2
Four weeks administrations of TTA-121 3U twice per day in morning and evening
After four weeks washout, four weeks administrations of placebo twice per day in morning and evening
Interventions/Control_3
Four weeks administrations of TTA-121 10U once per day in morning and placebo once per day in evening
After four weeks washout, four weeks administrations of placebo twice per day in morning and evening
Interventions/Control_4
Four weeks administrations of TTA-121 10U twice per day in morning and evening
After four weeks washout, four weeks administrations of placebo twice per day in morning and evening
Interventions/Control_5
Four weeks administrations of placebo twice per day in morning and evening
After four weeks washout, four weeks administrations of TTA-121 3U once per day in morning and placebo once per day in evening
Interventions/Control_6
Four weeks administrations of placebo twice per day in morning and evening
After four weeks washout, four weeks administrations of TTA-121 3U twice per day in morning and evening
Interventions/Control_7
Four weeks administrations of placebo twice per day in morning and evening
After four weeks washout, four weeks administrations of TTA-121 10U once per day in morning and placebo once per day in evening
Interventions/Control_8
Four weeks administrations of placebo twice per day in morning and evening
After four weeks washout, four weeks administrations of TTA-121 10U twice per day in morning and evening
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
1) Diagnosis of autism spectrum disorder based on Diagnostic and Statistical Manual of Mental Disorders-V with score exceeding the cut-off value of 10 for qualitative abnormalities in social reciprocity on ADIR
2) Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III
3) Written informed consent for participating the trial
Key exclusion criteria
(1) Diagnosis of bipolar disorder or schizophrenia spectrum disorder
(2) Primary diagnosis of depressive disorders, obsessive-compulsive and related disorders, anxiety disorders, trauma- and stressor-related disorders, dissociative disorders, somatic symptom and related disorders, or neurodevelopmental disorders other than autism spectrum disorder
(3) instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders
(4) history of changes in medication or doses of psychotropics within one month before registration
(5) current treatment with more than one psychotropics
(6) history of hyper-sensitivity to oxytocin;
(7) history of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes
(8) history of alcohol-related disorders, substance abuse, or addiction
(9) Family history of male breast cancer
(10) Subject who has severe complications
(11) Known hypersensitivity to some drugs and foods
(12) Subject who is not able to consent contraception during study period
(13) Pariticipation in another registration clinical trial and administration of investigational drug during 120 days before informed consent
(14) Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenori Yamasue |
Organization
Hamamatsu University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
TEL
053-435-2295
yamasue@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidenori Yamasue |
Organization
Hamamatsu University Hospital, Center for Clinical Research
Division name
Translational Research Center, TTA-121 recruiting office
Zip code
Address
1-20-1 Handayama, Higashiku, Hamamatsu City 431-3192, Japan
TEL
053-435-2008
Homepage URL
https://www.hama-med.ac.jp/hos/
hm.TTA-121@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine, Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
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
各機関でIRB承認後に順次公開
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 27 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 22 | Day |
Last modified on
| 2022 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035729
