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Gabitril

Phase 3

Generalized Anxiety Disorder | Small molecule | Psychiatry |Teva Pharmaceutical Industries Limited|Last Updated: May 9, 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 Trials2
Total Enrollment880
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00236054A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety DisorderPHASE3 COMPLETED 440Oct 1, 2004Dec 1, 2005May 9, 201419 United States
NCT00236067A 10-Week Study for Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety DisorderPHASE3 COMPLETED 440Oct 1, 2004Mar 1, 2006May 9, 201421 United States
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Study Endpoints
Primary Endpoints
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to endpoint in the total score of the HAM-A scale.
Secondary Endpoints
Assessment of proportion of responders and
patients in remission according to HAM-A scores and CGI ratings by
visit, assessment of the safety and tolerability in patients with GAD
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
GabitrilDRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S). Exclusi...

Countries:United States
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