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Completed

NCT Number: NCT00394056

Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.

Tinnitus associated to hearing loss is a high prevalent audiologic disorder with important unmet needs as far as therapy is concerned. The present study is exploring the possible beneficial effects on tinnitus loudness or annoyance of a combination drug treatment aimed to increase the local inhibitory activity of neural circuitries involved in sound perception and generation. Modest effects have been reported after 8-12 weeks treatment with antidepressants, including high dose paroxetine (up to 50 mg/day). Biologic data suggests that the combination of increase of extracellular serotonin using an SSRI and of blockade of NK1 receptors using a novel NK1 antagonist may lead to a reduced tinnitus and, possibly, improved hearing acuity. To this aim, two 14 day treatment conditions, i.e., SSRI paroxetine (20 mg/day) plus the NK1 antagonist vestipitant (25mg /day) or vestipitant alone (25 mg /day), will be compared to placebo in patients suffering from tinnitus previously selected for their capacity to reliably score the transient attenuation of tinnitus loudness produced by lidocaine infusion. Effects on principal endpoints will be collected within 4 hrs from last administration, when the plasma levels of vestipitant are calculated to be in the range associated to pharmacodynamic effects on VAS anxiety and qEEG (>30 ng/ml). PK, safety and tolerability of the paroxetine-vestipitant combination was addressed with preclinical and Phase I studies, showing no relevant issue. The cross-over study will require approximately 24 patients. Audiometry and computer-based Automated Psychoacoustics will be performed as instrumental endpoints to support subjective scores. A diary will be used at home to score tinnitus severity at home during the study.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 2GG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 control.
  • Women of non-childbearing potential.

Exclusion criteria

  • Subject with THI severity grade = 5 or less than or equal to 2.
  • Subject with pathologic level of anxiety or depression.
  • Subject with no audiogram deficit and with normal hearing.
  • Subjects that do not respond to the lidocaine infusion test or show a large variability in pre-infusion values.
  • Subjects with any serious medical or surgical condition
  • Subjects positive for drug use and/or a history of substance abuse or dependence.
  • Subjects who have taken psychotropic drugs or antidepressants within specified time frames.
  • Subjects who have recently used an investigational drug or recently participated in a trial.
  • Subjects who have exhibited intolerance to NK1 antagonists or SSRIs.
  • Women who have a positive pregnancy test.
  • Female subjects who intend to get pregnant or male subjects who intend to father a child within the next 4 weeks following the last study drug administration in the study.
  • Subjects, who have donated a unit of blood or more within the previous month or who intend to donate blood within one month of completing the study.

Treatment and study plan

Vestipitant

Drug

NK1 receptor antagonist

Vestipitant + Paroxetine

Drug

NK1 receptor antagonist and SSRI

Other names: Vestipitant

Placebo

Other

Placebo

Primary outcomes

  1. 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).

    Time frame: 2 hrs after dosing (or at any other time point vs. pre-dose baseline).

Secondary outcomes

  1. VAS to measure tinnitus pitch, distress and anxiety. Pure Tone Audiometry & Psychoacoustic assessment. Sleep & Tinnitus questionnaires. Safety, tolerability and pharmacokinetics of drug.

    Time frame: perceived at the moment of the measurement at 2 hrs after dosing (or at any other time point vs. pre-dose baseline).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Randomised, Double-blind, Placebo Controlled, Cross-over Study Comparing the Effects of Both Single Dose and Repeated Dosing Treatment for 14 Days of Vestipitant or Vestipitant / Paroxetine Combination in an Enriched Population of Subjects With Tinnitus & Hearing Loss

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 31, 2006
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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