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ONO-1110-08:A Phase IIa, Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Trial to Evaluate the Efficacy and Safety of ONO-1110 in Patients with Social Anxiety Disorder

ONO-1110-08:Phase IIa study of ONO-1110 in Patients with Social Anxiety Disorder

Terasawa Tetsuji

Ono Pharmaceutical Co.,LTD

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

clinical_trial@ono-pharma.com

JP Clinical Trial Support Desk

Ono Pharmaceutical Co.,LTD

1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan

+81-120-278-120

clinical_trial@ono-pharma.com

Not Recruiting

Jan. 17, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1.Japanese participants (sex not specified)
2.Participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements
3.Participants diagnosed with social anxiety disorder based on DSM-5-TR criteria, as determined through an interview using the M.I.N.I.
4.Outpatients
5.Participants with a LSAS-J total score of 70 or higher and a CGI-S score of 4 or higher

1.Participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria:
- Participants with a comorbid psychiatric disorder other than social anxiety disorder as defined by DSM-5-TR (assessed using the M.I.N.I.)
- Participants with a comorbid or past history of schizophrenia or other psychotic disorders as defined by DSM-5-TR

Both

Social Anxiety Disorder

The IMP is administered as follows according to the assigned administration group.
- ONO-1110 group: Take ONO-1110 tablets once a day.
- Placebo group: Take placebo tablets once daily.

Efficacy:
The change in the total LSAS-J score from baseline

Efficacy
Safety:
Adverse events, body weight, Vital signs, 12-lead electrocardiogram, Clinical laboratory test, C-SSRS
Pharmacokinetics

+81-42-648-5551

Dec. 13, 2024

No

none