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pagoclone

Phase 2

Stuttering | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 28, 2012

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment321
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00830154A Study to Assess the Efficacy and Safety of Pagoclone for Adults With StutteringPHASE2 COMPLETED 321Feb 1, 2009Jan 1, 2011Aug 28, 20121 United States
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Study Endpoints
Primary Endpoints
To assess whether treatment with pagoclone 0.30 mg BID or 0.60 mg BID reduces the percentage of syllables stuttered in people who stutter compared with placebo.
Weeks 8, 16 and 24
Secondary Endpoints
Improvement in the Clincal Global Impressions-improvement (CGI-I)scale. Patient Global Assessment of Stuttering (PGS-S) assessment. Liebowitz Social Anxiety Scale (LSAS) scores.
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL0.30 mg pagoclone BID
2EXPERIMENTAL0.60 mg pagoclone BID
3PLACEBO_COMPARATORplacebo
Interventions
NameTypeDescription
pagocloneDRUG0.30 mg BID, 0.60 mg BID
placeboOTHERplacebo
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and females age 18 to 80 years presenting with a history of stuttering with onset prior to age 8 years old. * Stuttering severity must be notable for \> 3 syllables stuttered on a reading and cenversational task at scereening and with at least 2% contributed individually ...

Countries:United States
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