drugset / Trial / NCT03466671
A Trial of TTA-121 on Autism Spectrum Disorder
Phase 2
Unknown
144 enrolled
Hamamatsu University
Japan Agency for Medical Research and Development · collab
RandomizedCrossoverQuadruple-blindTreatment
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
Timeline
- Start
- 2018-02-27
- Primary completion
- 2020-03-16
- Completion
- 2020-03-30
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxytocin | Peptide | 3 iu | Intranasal |
| Subject | Oxytocin | Peptide | 10 iu | Intranasal |