Autism Spectrum DisorderPhase 2NCT03466671

A Trial of TTA-121 on Autism Spectrum Disorder

A Phase 2 study testing TTA-121 in people with Autism Spectrum Disorder, run by Hamamatsu University at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses Read more about this study

Who is it for?: Ages 18 to 54 years, men only
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: TTA-121
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 1 siteJapan
Study dates: 27 Feb 2018to 30 Mar 2020
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 54 years
Men only
No healthy volunteers
Adult

Who may be able to join

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 Autism Diagnostic Interview Revised (ADIR)
Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III
Written informed consent for participating the trial

Who cannot join

Diagnosis of bipolar disorder or schizophrenia spectrum disorder
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 spectr um disorder
Instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders
History of changes in medication or doses of psychotropics within one month before registration
Current treatment with more than one psychotropics
History of hyper-sensitivity to oxytocin

Show all 14Show fewer

History of seizures or traumatic brain injury with loss of consciousness for longer than 5 minutes
History of alcohol-related disorders, substance abuse, or addiction
Family history of male breast cancer
Subject who has severe complications
Known hypersensitivity to some drugs and foods
Subject who is not able to consent contraception during study period
Participation in another registration clinical trial and administration of investigational drug during 120 days before informed consent
Other Subjects whom a lead investigator or the patient's primary physician deems are not appropriate for this study

Trial locations and contacts

1 site in 1 country.

Japan1 site

Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192

Other trials in Japan

About this study

Official title: An Early Phase II Trial for Efficacy and Safety of TTA-121 on Autism Spectrum Disorder

To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses

Conditions: Autism Spectrum Disorder
Being tested: TTA-121
Medical subject headings: Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TTA-121Drug
A nove intranasal spray of oxytocin and placebo

Study groups in NCT03466671
Study group	Role	What they receive
Low dose once per day and placebo	Other	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. Receives: Drug: TTA-121
Low dose twice per day and placebo	Other	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. Receives: Drug: TTA-121
High dose once per day and placebo	Other	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. Receives: Drug: TTA-121
High dose twice per day and placebo	Other	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. Receives: Drug: TTA-121
Placebo and low dose once per day	Other	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. Receives: Drug: TTA-121
Placebo and low dose twice per day	Other	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. Receives: Drug: TTA-121
Placebo and high dose once per day	Other	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. Receives: Drug: TTA-121
Placebo and high dose twice per day	Other	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. Receives: Drug: TTA-121

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
Changes in social reciprocity score (range: 0-14, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration

Secondary outcomes (9)

Efficacy on autism spectrum core symptom assessed by communication score on the Autism Diagnostic Observation Schedule module 4
Changes in communication score (range: 0-8, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
Changes in repetitive and restricted behavior score (range: 0-10, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy on autism spectrum core symptom assessed by revised algorithm score of social affect on the Autism Diagnostic Observation Schedule module 4
Changes in revised algorithm score of social affect (range: 0-20, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy on autism spectrum core symptom assessed by revised algorithm of repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
Changes in revised algorithm of repetitive and restricted behavior score (range: 0-10, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy assessed by Clinical Global Impression-Improvement
Changes in Clinical Global Impression-Improvement (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration
Efficacy assessed by Clinical Global Impression-Severity
Changes in Clinical Global Impression-Severity (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration
Efficacy assessed by Global Assessment of Functioning
Changes in Global Assessment of Functioning (range: 1-100, Higher value represent a better outcome) between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration
Efficacy assessed by gaze fixation time on social region
Changes in gaze fixation time on social region during being talked between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 60 min after the last drug administration
Efficacy assessed by quantitative analysis of facial expression
Changes in quantitative measure of facial expression on videos recorded during ADOS administration between baseline and endpoint of each administration period
Measured: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 201830 Mar 2020

First posted15 Mar 2018
Study start27 Feb 2018
Primary completion16 Mar 2020 (estimated)
Study completion30 Mar 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 144 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03466671
Sponsor's protocol ID: UMIN000031412
Status last verified: Dec 2019
First submitted: 28 Feb 2018
Last updated: 20 Dec 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wakuda T, Benner S, Uemura Y, Nishimura T, Kojima M, Kuroda M, Matsumoto K, Kanai C, Inada N, Harada T, Kameno Y, Munesue T, Inoue J, Umemura K, Yamauchi A, Ogawa N, Kushima I, Suyama S, Saito T, Hamada J, Kano Y, Honda N, Kikuchi S, Seto M, Tomita H, Miyoshi N, Matsumoto M, Kawaguchi Y, Kanai K, Ikeda M, Nakamura I, Isomura S, Hirano Y, Onitsuka T, Ozaki N, Kosaka H, Okada T, Kuwabara H, Yamasue H. Oxytocin-induced increases in cytokines and clinical effect on the core social features of autism: Analyses of RCT datasets. Brain Behav Immun. 2024 May;118:398-407. doi: 10.1016/j.bbi.2024.03.013. Epub 2024 Mar 8.
PubMed 38461957
Yamasue H, Kojima M, Kuwabara H, Kuroda M, Matsumoto K, Kanai C, Inada N, Owada K, Ochi K, Ono N, Benner S, Wakuda T, Kameno Y, Inoue J, Harada T, Tsuchiya K, Umemura K, Yamauchi A, Ogawa N, Kushima I, Ozaki N, Suyama S, Saito T, Uemura Y, Hamada J, Kano Y, Honda N, Kikuchi S, Seto M, Tomita H, Miyoshi N, Matsumoto M, Kawaguchi Y, Kanai K, Ikeda M, Nakamura I, Isomura S, Hirano Y, Onitsuka T, Kosaka H, Okada T. Effect of a novel nasal oxytocin spray with enhanced bioavailability on autism: a randomized trial. Brain. 2022 Apr 18;145(2):490-499. doi: 10.1093/brain/awab291.
PubMed 35067719

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Early Phase II Trial for Efficacy and Safety of TTA-121 on Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT03466671
Acronym / sponsor ID: UMIN000031412
Conditions: Autism Spectrum Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 144 participants (estimated)
Lead sponsor: Hamamatsu UniversityUniversity, hospital or other
Collaborators: Japan Agency for Medical Research and Development
Study start: 27 Feb 2018 (actual)
Primary completion: 16 Mar 2020 (estimated)
Study completion: 30 Mar 2020 (estimated)
First posted: 15 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To test efficacy and safety of a novel nasal spray of oxytocin on social deifies in autism spectrum disorder, and To compare effect sizes of different doses

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Low dose once per day and placebo	Other	Drug: TTA-121Four 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.
Low dose twice per day and placebo	Other	Drug: TTA-121Four 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.
High dose once per day and placebo	Other	Drug: TTA-121Four 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.
High dose twice per day and placebo	Other	Drug: TTA-121Four 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.
Placebo and low dose once per day	Other	Drug: TTA-121Four 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.
Placebo and low dose twice per day	Other	Drug: TTA-121Four 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.
Placebo and high dose once per day	Other	Drug: TTA-121Four 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.
Placebo and high dose twice per day	Other	Drug: TTA-121Four 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.

Who may qualify

Ages: 18 to 54 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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 Autism Diagnostic Interview Revised (ADIR)
Full scale Intelligent quotient above 80 as measured using the Wechsler Adult Intelligent Scale-III
Written informed consent for participating the trial

Key exclusion criteria (14 listed)

Diagnosis of bipolar disorder or schizophrenia spectrum disorder
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 spectr um disorder
Instability in symptoms of comorbid mental disorders such as depressive disorders or anxiety disorders
History of changes in medication or doses of psychotropics within one month before registration
Current treatment with more than one psychotropics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TTA-121A nove intranasal spray of oxytocin and placebo	Drug	High dose once per day and placebo, High dose twice per day and placebo, Low dose once per day and placebo, Low dose twice per day and placebo, Placebo and high dose once per day, Placebo and high dose twice per day, Placebo and low dose once per day, Placebo and low dose twice per day

Primary outcome

Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Changes in social reciprocity score (range: 0-14, Higher value represent a worth outcome) on Autism Diagnostic Observation Schedule module 4 between baseline and endpoint of each administration period

9 secondary outcomes

Efficacy on autism spectrum core symptom assessed by communication score on the Autism Diagnostic Observation Schedule module 4
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy on autism spectrum core symptom assessed by revised algorithm score of social affect on the Autism Diagnostic Observation Schedule module 4
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy on autism spectrum core symptom assessed by revised algorithm of repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration
Efficacy assessed by Clinical Global Impression-Improvement
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration
Efficacy assessed by Clinical Global Impression-Severity
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration
Efficacy assessed by Global Assessment of Functioning
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was assessed within 100 min after the last drug administration
Efficacy assessed by gaze fixation time on social region
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 60 min after the last drug administration
Efficacy assessed by quantitative analysis of facial expression
Time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
Derived from this study: PubMed 38461957Wakuda T, Benner S, Uemura Y, Nishimura T, Kojima M, Kuroda M, Matsumoto K, Kanai C, Inada N, Harada T, Kameno Y, Munesue T, Inoue J, Umemura K, Yamauchi A, Ogawa N, Kushima I, Suyama S, Saito T, Hamada J, Kano Y, Honda N, Kikuchi S, Seto M, Tomita H, Miyoshi N, Matsumoto M, Kawaguchi Y, Kanai K, Ikeda M, Nakamura I, Isomura S, Hirano Y, Onitsuka T, Ozaki N, Kosaka H, Okada T, Kuwabara H, Yamasue H. Oxytocin-induced increases in cytokines and clinical effect on the core social features of autism: Analyses of RCT datasets. Brain Behav Immun. 2024 May;118:398-407. doi: 10.1016/j.bbi.2024.03.013. Epub 2024 Mar 8.
Derived from this study: PubMed 35067719Yamasue H, Kojima M, Kuwabara H, Kuroda M, Matsumoto K, Kanai C, Inada N, Owada K, Ochi K, Ono N, Benner S, Wakuda T, Kameno Y, Inoue J, Harada T, Tsuchiya K, Umemura K, Yamauchi A, Ogawa N, Kushima I, Ozaki N, Suyama S, Saito T, Uemura Y, Hamada J, Kano Y, Honda N, Kikuchi S, Seto M, Tomita H, Miyoshi N, Matsumoto M, Kawaguchi Y, Kanai K, Ikeda M, Nakamura I, Isomura S, Hirano Y, Onitsuka T, Kosaka H, Okada T. Effect of a novel nasal oxytocin spray with enhanced bioavailability on autism: a randomized trial. Brain. 2022 Apr 18;145(2):490-499. doi: 10.1093/brain/awab291.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hidenori Yamasue, MD, PhD principal investigator

Department of Psychiatry, Hamamatsu University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TTA-121 in people with Autism Spectrum Disorder, run by Hamamatsu University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4 (time frame: At baseline, which was before and on the same day as the first administration, and at endpoint, which was started approximately 15 min after the last drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03466671, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.