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Trial record 22 of 330 for:    autism | Recruiting, Not yet recruiting, Available Studies

A Trial of TTA-121 on Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03466671
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
Japan Agency for Medical Research and Development
Information provided by (Responsible Party):
Hidenori Yamasue, M.D., Ph.D., Hamamatsu University

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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: TTA-121 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Early Phase II Trial for Efficacy and Safety of TTA-121 on Autism Spectrum Disorder
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : September 16, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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

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

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.

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

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

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

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

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

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




Primary Outcome Measures :
  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 ]
    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 :
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Changes in quantitative measure of facial expression on videos recorded during ADOS administration between baseline and endpoint of each administration period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 54 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466671


Contacts
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Contact: Hidenori Yamasue, MD, PhD +81-53-435-2295 yamasue@hama-med.ac.jp

Locations
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Japan
Hamamatsu University School of Medicine Recruiting
Hamamatsu, Shizuoka, Japan, 431-3192
Contact: Hidenori Yamasue, MD, PhD    +81-53-435-2008    hm.TTA-121@hama-med.ac.jp   
Sponsors and Collaborators
Hamamatsu University
Japan Agency for Medical Research and Development
Investigators
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Principal Investigator: Hidenori Yamasue, MD, PhD Department of Psychiatry, Hamamatsu University School of Medicine

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Responsible Party: Hidenori Yamasue, M.D., Ph.D., Professor, Hamamatsu University
ClinicalTrials.gov Identifier: NCT03466671     History of Changes
Other Study ID Numbers: UMIN000031412
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders