A Trial of TTA-121 on Autism Spectrum Disorder

NCT03466671 | Unknown Phase 2 DMC

• 1 other identifier: UMIN000031412
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  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

  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

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Drug: TTA-121

Interventions

TTA-121 DRUG

A nove intranasal spray of oxytocin and placebo

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

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hamamatsu University: lead
• Japan Agency for Medical Research and Development: collaborator

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Related Publications (2)

• 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.

  PMID: 38461957 DERIVED

• 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.

  PMID: 35067719 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Hidenori Yamasue, MD, PhD

  Department of Psychiatry, Hamamatsu University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 15, 2018
• Study Start: February 27, 2018
• Primary Completion: March 16, 2020
• Study Completion: March 30, 2020
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)