Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
piribedil
2 other identifiers
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2008
CompletedMarch 7, 2008
December 1, 2007
1.1 years
December 26, 2007
March 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
THI - Tinnitus Handicap Inventory
Months 3 and 6
Secondary Outcomes (1)
VAS - Visual Analog Scale
Months 3 and 6
Interventions
50 mg once a day, after lunch 3 month therapy
Eligibility Criteria
You may qualify if:
- tinnitus for more than 6 months
- THI \> 38
- no central acting drugs in the last 6 months
- tympanogram type A-n
You may not qualify if:
- vascular and muscular tinnitus
- concomitant TMJ disorders
- abnormal otoscopy
- mixed and conductive hearing losses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OTOSUL,Otorrinolaringologia Sul-Fluminense
Volta Redonda, Rio de Janeiro, 27255-650, Brazil
Related Publications (1)
de Azevedo AA, Langguth B, de Oliveira PM, Rodrigues Figueiredo R. Tinnitus treatment with piribedil guided by electrocochleography and acoustic otoemissions. Otol Neurotol. 2009 Aug;30(5):676-80. doi: 10.1097/MAO.0b013e3181ab8fd5.
PMID: 19574947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 11, 2008
Study Start
November 1, 2006
Primary Completion
December 1, 2007
Last Updated
March 7, 2008
Record last verified: 2007-12