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BGG492A

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

BGG492A · 1 trial · 1 indication

Phase 2 1
NCT01302873Study of BGG492 in Patients With Chronic Subjective TinnitusChronic Subjective Tinnitus
COMPLETED96 Analytics
PHASE2COMPLETED
Study of BGG492 in Patients With Chronic Subjective Tinnitus
Chronic Subjective TinnitusUnlock trial analytics

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 to 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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Frequently asked questions about BGG492A

What is BGG492A used for?

BGG492A is an investigational small molecule being studied for the treatment of chronic subjective tinnitus, a condition characterized by persistent ringing or noise in the ears without an external source. It is in Phase 2 clinical development and has not been approved by regulatory authorities.

What does BGG492A target?

The molecular target of BGG492A has not been disclosed in available information. It is a small molecule being developed by Novartis AG for chronic subjective tinnitus, but its specific mechanism of action is not publicly detailed.

Who makes BGG492A?

BGG492A is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for chronic subjective tinnitus.

What phase is BGG492A in?

BGG492A is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that has not received approval from the U.S. Food and Drug Administration or other regulatory agencies.

What clinical trials is BGG492A in?

BGG492A has been studied in one completed Phase 2 clinical trial with the identifier NCT01302873. This randomized, double-blind, placebo-controlled trial enrolled 96 participants with chronic subjective tinnitus and was conducted at sites in Germany and the Netherlands.

Is BGG492A the same as BGG492?

BGG492A is the drug name used in clinical trial records, and it may also be referred to as BGG492 in some contexts. The completed Phase 2 study NCT01302873 lists the intervention as BGG492, indicating these names refer to the same investigational compound.