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PH94B intranasal

Phase 2

Social Phobia | Small molecule | Psychiatry |Vistagen Therapeutics, Inc.|Trials Updated: May 10, 2011

PH94B intranasal target and mechanism

ModalitySmall molecule

Also known as PH94B intranasal spray

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

PH94B intranasal clinical trials

PH94B intranasal · 1 trial · 2 indications

Phase 2 1
NCT01217788Intranasal PH94B for Management of the Symptoms of Generalized Social PhobiaSocial Phobia
COMPLETED90 Analytics
PHASE2COMPLETED
Intranasal PH94B for Management of the Symptoms of Generalized Social Phobia
Social PhobiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Subjective Unit of Discomfort Scale
Once before and again 10 minutes after intranasal dosing with PH94B spray, during exposure to a public speaking challenge

Secondary Endpoints

Number of patients with adverse events as a measure of safety and tolerability on the psychometric scale
Once at the end of the intervention and again one week after intervention (follow-up)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PH94B intranasal sprayEXPERIMENTAL -
Placebo intranasal sprayPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PH94B intranasal sprayDRUGComparison of PH94B single dose intranasal spray and Placebo single dose intranasal spray
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject currently meets the Diagnosis of Social Phobia as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th Edition which is not secondary to another pre-existing psychiatric condition or to a medical condition. * Liebowitz Social Anxiety Scale (LSAS) score...

Countries:United States
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Frequently asked questions about PH94B intranasal

What is PH94B intranasal used for?

PH94B intranasal is an investigational therapy being studied for the management of symptoms of social phobia, also known as social anxiety disorder. It is administered as an intranasal spray. The clinical program has focused on adults with this condition, and the drug has not been approved for any indication.

Who is developing PH94B intranasal?

PH94B intranasal is being developed by Vistagen Therapeutics, Inc., which trades on the Nasdaq under the ticker VTGN. The company is the sponsor of the clinical program evaluating the intranasal spray for social phobia.

What phase is PH94B intranasal in?

PH94B intranasal is in Phase 2 clinical development. A completed Phase 2 trial evaluated the intranasal spray in adults with social phobia. The drug remains investigational and has not been approved by the FDA for any use.

What clinical trials is PH94B intranasal in?

PH94B intranasal has been studied in a completed Phase 2 trial, NCT01217788, titled Intranasal PH94B for Management of the Symptoms of Generalized Social Phobia. The trial enrolled 90 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.

Is PH94B intranasal the same as PH94B intranasal spray?

Yes. PH94B intranasal and PH94B intranasal spray refer to the same investigational product. The spray designation describes the intranasal route of administration used in the clinical program for social phobia.