Clinical trial NCT03466671: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Hamamatsu University
Sponsor class: OTHER
Collaborators: name: Japan Agency for Medical Research and Development
First posted: 2018-03-15
Enrollment: 144
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy on autism spectrum social core symptom assessed by social reciprocity score on the Autism Diagnostic Observation Schedule module 4
timeFrame: 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:
measure: Efficacy on autism spectrum core symptom assessed by communication score on the Autism Diagnostic Observation Schedule module 4
timeFrame: 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
measure: Efficacy on autism spectrum core symptom assessed by repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
timeFrame: 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
measure: Efficacy on autism spectrum core symptom assessed by revised algorithm score of social affect on the Autism Diagnostic Observation Schedule module 4
timeFrame: 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
measure: Efficacy on autism spectrum core symptom assessed by revised algorithm of repetitive and restricted behavior score on the Autism Diagnostic Observation Schedule module 4
timeFrame: 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
measure: Efficacy assessed by Clinical Global Impression-Improvement
timeFrame: 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
measure: Efficacy assessed by Clinical Global Impression-Severity
timeFrame: 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
measure: Efficacy assessed by Global Assessment of Functioning
timeFrame: 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
measure: Efficacy assessed by gaze fixation time on social region
timeFrame: 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
measure: Efficacy assessed by quantitative analysis of facial expression
timeFrame: 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
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
state: Shizuoka
Study officials:
affiliation: Department of Psychiatry, Hamamatsu University School of Medicine
name: Hidenori Yamasue, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.