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OpenTrials
Completed

NCT Number: NCT00591994

Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Tinnitus is defined as the perception of sound in the absence of a external source. About 15 % of the population is believed to experience tinnitus and for about 20 % of them it may become a very serious problem. Total comprehension of tinnitus pathophysiology has not yet been achieved, but modern theories focus in brain hyperactivity following inner ear damage, with involvement of various neurotransmitters. Piribedil,a dopamin agonist, has been used to treat tinnitus, focusing in dopamine release, which is inhibitory. Electrophysiological methods,like acoustic otoemissions and electrocochleography may reveal the changes in peripherical and central auditory pathways and help to choose the specific patients who could benefit from piribedil treatment.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OTOSUL,Otorrinolaringologia Sul-Fluminense

Volta Redonda, Rio de Janeiro, 27255-650, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • tinnitus for more than 6 months
  • THI > 38
  • no central acting drugs in the last 6 months
  • tympanogram type A-n

Exclusion criteria

  • vascular and muscular tinnitus
  • concomitant TMJ disorders
  • abnormal otoscopy
  • mixed and conductive hearing losses

Treatment and study plan

Piribedil

Drug

50 mg once a day, after lunch 3 month therapy

Primary outcomes

  1. THI - Tinnitus Handicap Inventory

    Time frame: Months 3 and 6

Secondary outcomes

  1. VAS - Visual Analog Scale

    Time frame: Months 3 and 6

Sponsors and collaborators

Lead sponsor

Faculdade de Medicina de Valenca

Other

Registry information

Acronym: piribedil

Important dates

Study start
2006
Primary completion
2007
First posted
Jan 11, 2008
Registry last updated
Mar 7, 2008

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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