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Trial · Interventional

Status unknownPhase 2Registry data

A Trial of TTA-121 on Autism Spectrum Disorder

NCTNCT03466671 (opens ClinicalTrials.gov in a new tab)Other idUMIN000031412
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
144 participants (estimated)
Sponsor
Hamamatsu University · Other
Design
Randomized · Quadruple masking
Countries
1 country

Japan

Start
27 Feb 2018
Primary completion
16 Mar 2020 (estimated)
Completion
30 Mar 2020 (estimated)
First posted
15 Mar 2018
Last update posted
20 Dec 2019
Conditions
Autism Spectrum Disorder

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 2

    A Trial of TTA-121 on Autism Spectrum Disorder

    NCT03466671

    27 Feb 2018 to est. 30 Mar 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • TTA-121Drug

Arms8

  • Other

    Low dose once per day and placebo

    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.

  • Other

    Low dose twice per day and placebo

    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.

  • Other

    High dose once per day and placebo

    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.

  • Other

    High dose twice per day and placebo

    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.

  • Other

    Placebo and low dose once per day

    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.

  • Other

    Placebo and low dose twice per day

    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.

  • Other

    Placebo and high dose once per day

    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.

  • Other

    Placebo and high dose twice per day

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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

Secondary outcomes(9)

  1. 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

    Registry description

    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

  2. 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

    Registry description

    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

  3. 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

    Registry description

    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

  4. 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

    Registry description

    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

  5. 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

    Registry description

    Changes in Clinical Global Impression-Improvement (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period

  6. 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

    Registry description

    Changes in Clinical Global Impression-Severity (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period

  7. 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

    Registry description

    Changes in Global Assessment of Functioning (range: 1-100, Higher value represent a better outcome) between baseline and endpoint of each administration period

  8. 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

    Registry description

    Changes in gaze fixation time on social region during being talked between baseline and endpoint of each administration period

  9. 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

    Registry description

    Changes in quantitative measure of facial expression on videos recorded during ADOS administration between baseline and endpoint of each administration period

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

4 results

Effect of a novel nasal oxytocin spray with enhanced bioavailability on autism: a randomized trial.

Yamasue et al. 2022Brain : a journal of neurologycited by 44

PMID 35067719DOI 10.1093/brain/awab291PUB-35067719

Rights unknown4 results
Source linkSee results (4)

More studies

1 study on this page

PubMed tag: none · 2024

Oxytocin-induced increases in cytokines and clinical effect on the core social features of autism: Analyses of RCT datasets.

Wakuda et al. 2024Brain, behavior, and immunitycited by 4

PMID 38461957DOI 10.1016/j.bbi.2024.03.013PUB-38461957

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 54 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 Autism Diagnostic Interview Revised (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 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 spectr um 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. Participation 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

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