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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031412
Receipt No. 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 2018/02/28

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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
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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 27 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 01 Month 15 Day
Date trial data considered complete
2020 Year 01 Month 31 Day
Date analysis concluded
2020 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 22 Day
Last modified on
2018 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035729

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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