NTX-1472 for Social Anxiety Disorder
(SOAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates a new treatment called NTX-1472 for Social Anxiety Disorder (SAD). Researchers aim to determine if NTX-1472 is safe and effective compared to a placebo (a pill with no medicine) in reducing SAD symptoms. Participants will take either NTX-1472 or a placebo daily for eight weeks and attend six clinic visits over 14 weeks. This trial suits adults diagnosed with generalized Social Anxiety Disorder who are not currently experiencing other significant psychiatric conditions. As a Phase 2 trial, this research measures how well NTX-1472 works in an initial, smaller group, offering participants a chance to contribute to developing a potential new treatment for SAD.
Will I have to stop taking my current medications?
If you are taking daily psychotropic medications, you will need to stop them at least 4 weeks before the screening for this trial.
Is there any evidence suggesting that NTX-1472 is likely to be safe for humans?
Research has shown that NTX-1472 has undergone testing in several studies. In these earlier tests, participants received varying doses of NTX-1472 to assess their bodily responses. The studies also explored how NTX-1472 interacts with other medications.
Results so far suggest that NTX-1472 is generally safe and well-tolerated, with no major safety issues reported. However, like any treatment, some individuals might experience side effects. It is important to note that these findings are from earlier tests, and the current study will provide more information about the safety of NTX-1472 for individuals with Social Anxiety Disorder.12345Why do researchers think this study treatment might be promising for Social Anxiety Disorder?
NTX-1472 is unique because, unlike traditional treatments for social anxiety disorder that often involve SSRIs or cognitive-behavioral therapy, it uses a novel mechanism of action to target the condition. Researchers are excited because NTX-1472 promises faster relief and potentially fewer side effects compared to current options. This innovative approach could provide a more effective and tolerable alternative for those struggling with social anxiety.
What evidence suggests that NTX-1472 might be an effective treatment for Social Anxiety Disorder?
Research shows that NTX-1472, which participants in this trial may receive, targets a specific part of the brain involved in social behavior. This treatment has shown promise in possibly reducing symptoms of social anxiety. Earlier studies found that NTX-1472 was safe and well-tolerated in initial trials, which is important for its potential use in treating Social Anxiety Disorder (SAD). While direct evidence on its effectiveness for SAD is still being gathered, its mechanism suggests it might help manage symptoms of the condition. Early results are promising, but more research is needed to confirm its benefits for people with SAD.13467
Are You a Good Fit for This Trial?
Adults aged 18-65 with a confirmed diagnosis of generalized Social Anxiety Disorder (SAD) as per DSM-5, who can speak English and have a moderate to severe level of social anxiety. They must not be significantly depressed and agree to use effective birth control if capable of childbearing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take NTX-1472 or matching placebo every day for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NTX-1472
Trial Overview
The trial is testing NTX-1472, a new drug for treating SAD by blocking V1a receptors. Over 8 weeks, participants will take either NTX-1472 or placebo daily and visit the clinic six times for checkups. The study aims to assess safety, tolerability, and effectiveness in reducing social anxiety symptoms.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Newleos Therapeutics, Inc.
Lead Sponsor
Citations
A Phase 2 Study of NTX-1472 in Social Anxiety Disorder
The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social ...
Newleos Therapeutics Announces Dosing of First ...
NTX-1472 has completed multiple Phase 1 studies, including Single Ascending Dose, Multiple Ascending Dose, and drug-drug interaction studies and ...
3.
biospace.com
biospace.com/press-releases/newleos-therapeutics-announces-clinical-progress-across-neuropsychiatric-pipelineNewleos Therapeutics Announces Clinical Progress ...
Newleos licensed NTX-1472 from Roche and plans to initiate a Phase 2 study in the U.S. to assess the safety, tolerability and efficacy of NTX- ...
NTX-1472 for Social Anxiety Disorder (SOAR Trial)
The study aims to assess safety, tolerability, and effectiveness in reducing social anxiety symptoms. How Is the Trial Designed? 2. Treatment ...
5.
trial.medpath.com
trial.medpath.com/clinical-trial/db382a2e1468e711/nct07323784-ntx-1472-v1a-receptor-antagonist-social-anxiety-disorderA Phase 2 Study of NTX-1472 in Social Anxiety Disorder
The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social Anxiety ...
A Phase 2 Study of NTX-1472 in Social Anxiety Disorder
The main questions this trial aims to answer are: Is NTX-1472 safe and well tolerated in adults with SAD?
7.
finance.yahoo.com
finance.yahoo.com/news/newleos-therapeutics-announces-dosing-first-120000268.htmlNewleos Therapeutics Announces Dosing of First ...
Participants will be randomized to receive NTX-1472 or matched placebo once daily for eight weeks. The primary endpoint is the incidence and ...
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