NCT04754802: Palisade-1

PH94B Nasal Spray for Anxiety Induced by a Public Speaking Challenge

Completed Phase 3 Results posted Last updated 12 September 2025

What this trial tests

Phase 3 trial testing PH94B Nasal Spray in Social Anxiety Disorder in 224 participants. Completed in 22 June 2022.

Timeline

24 May 2021

Primary endpoint
22 June 2022

22 June 2022

Quick facts

Lead sponsor	VistaGen Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	224
Start date	24 May 2021
Primary completion	22 June 2022
Estimated completion	22 June 2022
Sites	21 locations across United States

Drugs / interventions tested

• PH94B Nasal Spray — full drug profile →
• Placebo Nasal Spray — full drug profile →

Conditions studied

• Social Anxiety Disorder — all drugs for Social Anxiety Disorder →

Sponsor

VistaGen Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Social Anxiety Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Units of Distress Scale (SUDS) Score Primary · Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)

The SUDS is a patient self-rated scale that is scored in the range of 0 to 100 (operationalized for participants in this study as 0=totally relaxed or no anxiety and 100=highest distress or anxiety ever felt

Visit 2

Group	Value	95% CI
PH94B	77.7	± 11.67
Placebo	78.2	± 12.42

Visit 3

Group	Value	95% CI
PH94B	62.3	± 19.40
Placebo	61.3	± 19.56

Proportions (%) of CGI-I Responders in PH94B-treated and Placebo-treated Groups at the End of Visit 3 (Treatment) Secondary · Visit 2 (Baseline; Day 0) to Visit 3 (Day 7 ± 2 days)

The CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item scored from 1 (Very much less anxious) to 7 (Very much more anxious) with 4 being no change. Subjects are considered CGI-I responders with scores of 1 (Very much less anxious) or 2 (Much less anxious

Group	Value	95% CI
PH94B	34
Placebo	36

Sponsor's own description

This Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute administration of 3.2 µg of PH94B to relieve symptoms of anxiety in adult subjects with social anxiety disorder (SAD) during an induced public speaking challenge.

Subject participation in the Study will last a total of 3 to 7 weeks, depending on the duration of the screening period and intervals between visits. Upon signing an informed consent, all subjects will complete Visit 1 (Screening) and enter a screening period lasting between 3 and 35 days. If subjects meet all eligibility criteria at the end of the screening period, subjects will return for Visit 2 and self-administer the nasal spray and then participate in a 5 minute public speaking challenge. During the public speaking challenge, the subject will be asked for their anxiety score, which will be recorded by a trained observer. At Visit 3, the subjects will undergo the same public speaking procedure once again as they did in Visit 2. One week after the completion of the Visit 3 public speaking challenge, the subject will come back for Visit 4 (Follow-up) that will involve a repeat of the safety and psychiatric assessments conducted at Screening.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
   Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
2. ACNP 62nd Annual Meeting: Poster Abstracts P1 – P250
   · 2023