A Trial of TTA-121 on Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03466671
• Other study ID #: UMIN000031412
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 27, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: December 2019
• Source: Hamamatsu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: March 30, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
Japan	Hamamatsu University School of Medicine	Hamamatsu	Shizuoka

Sponsors (2)

Lead Sponsor	Collaborator
Hamamatsu University	Japan Agency for Medical Research and Development

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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	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	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	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	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	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	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
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	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	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