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Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography (piribedil)
This study has been completed.
Sponsored by: Faculdade de Medicina de Valenca
Information provided by: Faculdade de Medicina de Valenca
ClinicalTrials.gov Identifier: NCT00591994
  Purpose

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.


Condition Intervention
Tinnitus
Drug: piribedil

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders
Drug Information available for: Piribedil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Further study details as provided by Faculdade de Medicina de Valenca:

Primary Outcome Measures:
  • THI - Tinnitus Handicap Inventory [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS - Visual Analog Scale [ Time Frame: Months 3 and 6 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2006
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: piribedil
    50 mg once a day, after lunch 3 month therapy
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00591994

Locations
Brazil, RJ
OTOSUL,Otorrinolaringologia Sul-Fluminense
Volta Redonda, RJ, Brazil, 27255-650
Sponsors and Collaborators
Faculdade de Medicina de Valenca
Investigators
Study Chair: Ricardo R Figueiredo, M.D.,M.Sc Faculdade de Medicina de Valença
Principal Investigator: Andréia A Azevedo, M.D. OTOSUL,Otorrinolaringologia Sul-Fluminense
  More Information

Tinnitus Center homepage  This link exits the ClinicalTrials.gov site

Responsible Party: OTOSUL ( Andréia Aparecida de Azevedo, M.D. )
Study ID Numbers: OTOSUL 01/2007, FMV 01/2006
Study First Received: December 26, 2007
Last Updated: March 6, 2008
ClinicalTrials.gov Identifier: NCT00591994  
Health Authority: Brazil: Ministry of Health

Keywords provided by Faculdade de Medicina de Valenca:
tinnitus
piribedil
acoustic otoemissions
ECoG

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Dopamine
Otorhinolaryngologic Diseases
Piribedil
Neurologic Manifestations
Ear Diseases
Tinnitus

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009