Clinical trial • Phase III • Psychiatry

NTX-1955 for Generalized anxiety disorder

Phase III trial of NTX-1955 for Generalized anxiety disorder. 60 participants.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Generalized anxiety disorder
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
23-06-2025
First CTIS Authorization Date
06-08-2025

Trial design

Phase III trial across 1 site in Netherlands.

Target Sample Size
60

Eligibility

Recruits 60 No vulnerable populations selected (isVulnerablePopulationSelected:false). Consent/assent handling not described..

Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected:false). Consent/assent handling not described.

Recruitment

Planned Sample Size
60
Recruitment Window Months
14

Geography

Total Number Of Sites
1
Total Number Of Participants
60

Netherlands

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
25-09-2025
Processing Time Days
64
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Centre for Human Drug Research
Department Name
Psychiatry
Contact Person Name
Gabriel Jacobs
Contact Person Email
clintrials@chdr.nl

Sponsor

Primary sponsor

Full Name
Newleos Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
NTX-1955
Routes Of Administration
oral
Route
oral

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