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BGG492A

Phase 2

Chronic Subjective Tinnitus | Small molecule | ENT |Novartis AG|Last Updated: Mar 22, 2017

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_CONTROLLED
Total Trials1
Total Enrollment96
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01302873Study of BGG492 in Patients With Chronic Subjective TinnitusPHASE2 COMPLETED 96 — — Jan 1, 2011Jan 1, 2012Mar 22, 20174 Germany, Netherlands
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Study Endpoints
Primary Endpoints
Change in tinnitus loudness using a visual analogue scale (VAS)
after 15 days of treatment
Change in Clinical status of tinnitus (patients' reaction to tinnitus) using the TBF-12 (Tinnitus Impairment Questionnaire)
after 15 days of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BGG492EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BGG492ADRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Patients diagnosed with THI (Tinnitus Handicap Inventory) severity grade 3, 4 or 5 (moderate, severe or catastrophic), chronic (\> 6 months and \< 36 months) subjective tinnitus * Willing to abstain from activities that require focused attention, e.g. driving a car or other ve...

Countries:GermanyNetherlands
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