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experimental anti-anxiety drug

Phase 3

Anxiety Disorder | Small molecule | Psychiatry |Jazz Pharmaceuticals plc|Last Updated: Oct 3, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment511

FDA Designations

No designations recorded

Clinical trial landscape

experimental anti-anxiety drug · 1 trial · 1 indication

Phase 3 1
NCT00097708Experimental Medication For the Treatment of Generalized Anxiety DisorderAnxiety Disorder
COMPLETED511 Analytics
PHASE3COMPLETED
Experimental Medication For the Treatment of Generalized Anxiety Disorder
Anxiety DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in HAM-A Total Score
Baseline to week 8

Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
experimental anti-anxiety drugDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites50

Inclusion Criteria: * Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD. Exclusion Criteria: * No other primary psychiatric diagnosis besides GAD.

Countries:United States
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Frequently asked questions about experimental anti-anxiety drug

What is the experimental anti-anxiety drug used for?

The experimental anti-anxiety drug is being developed for the treatment of Anxiety Disorder, specifically generalized anxiety disorder. It is a small molecule being studied in the psychiatry therapeutic area. The drug is currently in Phase 3 clinical development.

Who makes the experimental anti-anxiety drug?

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is developing the experimental anti-anxiety drug. The company is conducting clinical trials for this small molecule intended to treat anxiety disorder. The drug is currently in Phase 3 development.

What phase is the experimental anti-anxiety drug in?

The experimental anti-anxiety drug is in Phase 3 clinical development. It is an investigational small molecule being studied for the treatment of anxiety disorder. The drug has completed one Phase 3 trial and is not yet approved by regulatory authorities.

What clinical trials is the experimental anti-anxiety drug in?

The experimental anti-anxiety drug has one completed Phase 3 clinical trial, NCT00097708, titled "Experimental Medication For the Treatment of Generalized Anxiety Disorder." This trial enrolled 511 participants in the United States, with adults aged 18 years and older, and included both male and female subjects.

Is the experimental anti-anxiety drug FDA approved?

The experimental anti-anxiety drug is not FDA approved. It is an investigational small molecule currently in Phase 3 clinical development for the treatment of anxiety disorder. The drug has completed one Phase 3 trial but remains under investigation and has not received regulatory approval.