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Vestipitant

Phase 2

Tinnitus | Small molecule | ENT |GSK plc|Last Updated: Oct 28, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Vestipitant · 2 trials · 2 indications

Phase 2 2
NCT00394056Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.Tinnitus
COMPLETED26 Analytics
NCT00343707PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety PatientsDepressive Disorder and Anxiety Disorders
COMPLETED72 Analytics
PHASE2COMPLETED
Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.
Tinnitus
NCT0039405626
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PHASE2COMPLETED
PET (Positron Emission Tomography)/Public Speaking Study With A Combination Of 2 Medications In Social Anxiety Patients
Depressive Disorder and Anxiety Disorders
NCT0034370772
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Study Endpoints

Primary Endpoints

Visual Analog Scales (VAS) to measure the change in tinnitus loudness as perceived at the moment of the measurement at 2 hrs after dosing (or at any other time point vs. pre-dose baseline).
2 hrs after dosing (or at any other time point vs. pre-dose baseline).
To assess, by mean of Positron Emission Tomography, the degree of regional Cerebral Blood Flow in different brain regions involved in the emotional brain circuit during public speaking task before treatment and after eight weeks of treatment.

Secondary Endpoints

VAS to measure tinnitus pitch, distress and anxiety. Pure Tone Audiometry & Psychoacoustic assessment. Sleep & Tinnitus questionnaires. Safety, tolerability and pharmacokinetics of drug.
perceived at the moment of the measurement at 2 hrs after dosing (or at any other time point vs. pre-dose baseline).
To assess symptomatic and physiological measures of anxiety induced by the public speaking task and social anxiety symptoms during eight weeks of treatment. To evaluate safety, tolerability and the effect on sexual function of treatment.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1OTHER -
Period 2OTHER -
Period 3OTHER -

Interventions

NameTypeDescription
VestipitantDRUGNK1 receptor antagonist
Vestipitant + ParoxetineDRUGNK1 receptor antagonist and SSRI
PlaceboOTHERPlacebo
paroxetineDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Male or female subjects with a diagnosed tinnitus. * Subject with THI severity grade of 3 or 4. * Subjects willing to restrict alcohol intake. * The subject must have given written consent. * Women of childbearing potential who abstain from intercourse OR agree to birth contro...

Countries:United KingdomSweden
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Competitive Landscape -Tinnitus 3 trials

No competing companies are currently tracked in active development for Tinnitus.
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Frequently asked questions about Vestipitant

What is Vestipitant used for?

Vestipitant is an investigational small molecule being studied for tinnitus, social phobia, depressive disorder, and anxiety disorders. It is in Phase 2 clinical development and is not approved by the FDA. The drug is being developed by GSK plc.

What does Vestipitant target?

Vestipitant is a small molecule being studied for tinnitus, social phobia, depressive disorder, and anxiety disorders. Its specific molecular target has not been disclosed in available clinical trial information. It is in Phase 2 development by GSK plc.

Who makes Vestipitant?

Vestipitant is being developed by GSK plc, which trades under the ticker GSK. The drug is an investigational small molecule in Phase 2 clinical trials for tinnitus, social phobia, depressive disorder, and anxiety disorders.

What phase is Vestipitant in?

Vestipitant is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. GSK plc is the developer, and the drug is being studied for tinnitus, social phobia, depressive disorder, and anxiety disorders.

What clinical trials is Vestipitant in?

Vestipitant has been studied in three completed Phase 2 trials: NCT00343707 for depressive disorder and anxiety disorders, NCT00394056 for tinnitus, and NCT00403962 for social phobia. These trials were conducted in Sweden, the United Kingdom, Denmark, Germany, Norway, and South Africa.

Is Vestipitant the same as other drugs?

Vestipitant has been studied in combination with paroxetine in clinical trials for tinnitus and social anxiety disorder. However, no alternative names for Vestipitant itself have been disclosed in the available trial information.