Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography (piribedil)

This study has been completed.
Sponsor:
Information provided by:
Faculdade de Medicina de Valenca
ClinicalTrials.gov Identifier:
NCT00591994
First received: December 26, 2007
Last updated: March 6, 2008
Last verified: December 2007
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Brazil
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

Additional Information:
No publications provided by Faculdade de Medicina de Valenca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andréia Aparecida de Azevedo, M.D., OTOSUL
ClinicalTrials.gov Identifier: NCT00591994     History of Changes
Other Study ID Numbers: OTOSUL 01/2007, FMV 01/2006
Study First Received: December 26, 2007
Last Updated: March 6, 2008
Health Authority: Brazil: Ministry of Health

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

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Piribedil
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014