Back to resultsA Trial of TTA-121 on Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TTA-121
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hamamatsu University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Other
Other
Other
Other
Other
Other
Other
Other
Arm Label
Low dose once per day and placebo
Low dose twice per day and placebo
High dose once per day and placebo
High dose twice per day and placebo
Placebo and low dose once per day
Placebo and low dose twice per day
Placebo and high dose once per day
Placebo and high dose twice per day
Arm Description
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.
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.
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT03466671
First Posted
February 28, 2018
Last Updated
December 18, 2019
Sponsor
Hamamatsu University
Collaborators
Japan Agency for Medical Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT03466671
Brief Title
A Trial of TTA-121 on Autism Spectrum Disorder
Official Title
An Early Phase II Trial for Efficacy and Safety of TTA-121 on Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
March 16, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamamatsu University
Collaborators
Japan Agency for Medical Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose once per day and placebo
Arm Type
Other
Arm Description
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.
Arm Title
Low dose twice per day and placebo
Arm Type
Other
Arm Description
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.
Arm Title
High dose once per day and placebo
Arm Type
Other
Arm Description
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.
Arm Title
High dose twice per day and placebo
Arm Type
Other
Arm Description
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.
Arm Title
Placebo and low dose once per day
Arm Type
Other
Arm Description
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.
Arm Title
Placebo and low dose twice per day
Arm Type
Other
Arm Description
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.
Arm Title
Placebo and high dose once per day
Arm Type
Other
Arm Description
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.
Arm Title
Placebo and high dose twice per day
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TTA-121
Intervention Description
A nove intranasal spray of oxytocin and placebo
Primary Outcome Measure Information:
Title
Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
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
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
Secondary Outcome Measure Information:
Title
Efficacy on autism spectrum core symptom assessed by communication score on the Autism Diagnostic Observation Schedule module 4
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
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
Title
Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
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
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
Title
Efficacy on autism spectrum core symptom assessed by revised algorithm score of social affect on the Autism Diagnostic Observation Schedule module 4
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
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
Title
Efficacy on autism spectrum core symptom assessed by revised algorithm of repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
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
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
Title
Efficacy assessed by Clinical Global Impression-Improvement
Description
Changes in Clinical Global Impression-Improvement (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period
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
Title
Efficacy assessed by Clinical Global Impression-Severity
Description
Changes in Clinical Global Impression-Severity (range: 1-7, Higher value represent a worse outcome) between baseline and endpoint of each administration period
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
Title
Efficacy assessed by Global Assessment of Functioning
Description
Changes in Global Assessment of Functioning (range: 1-100, Higher value represent a better outcome) between baseline and endpoint of each administration period
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
Title
Efficacy assessed by gaze fixation time on social region
Description
Changes in gaze fixation time on social region during being talked between baseline and endpoint of each administration period
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
Title
Efficacy assessed by quantitative analysis of facial expression
Description
Changes in quantitative measure of facial expression on videos recorded during ADOS administration between baseline and endpoint of each administration period
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hidenori Yamasue, MD, PhD
Organizational Affiliation
Department of Psychiatry, Hamamatsu University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35067719
Citation
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.
Results Reference
derived
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A Trial of TTA-121 on Autism Spectrum Disorder
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