UMIN-CTR Clinical Trial

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
Email	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/
Email	hm.TTA-121@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine, Department of Psychiatry
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035729