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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment511
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00097708Experimental Medication For the Treatment of Generalized Anxiety DisorderPHASE3 COMPLETED 511Nov 1, 2004Dec 1, 2005Oct 3, 201450 United States
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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 — 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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