TinnituspiribedilNCT00591994
Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
A study testing piribedil in people with Tinnitus, run by Faculdade de Medicina de Valenca at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- piribedil
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tinnitus for more than 6 months
- THI > 38
- no central acting drugs in the last 6 months
- tympanogram type A-n
Who cannot join
- vascular and muscular tinnitus
- concomitant TMJ disorders
- abnormal otoscopy
- mixed and conductive hearing losses
Trial locations and contacts
1 site in 1 country.
Brazil1 site
OTOSUL,Otorrinolaringologia Sul-Fluminense
Volta Redonda, Rio de Janeiro, 27255-650
About this study
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.
- Conditions
- Tinnitus
- Being tested
- piribedil
- Keywords
- tinnitus, piribedil, acoustic otoemissions, ECoG
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
piribedilDrug
50 mg once a day, after lunch 3 month therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
THI - Tinnitus Handicap Inventory
Measured: Months 3 and 6
Secondary outcomes (1)
VAS - Visual Analog Scale
Measured: Months 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Medicina de Valenca
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo R Figueiredo, M.D.,M.Sc, Study chair, Faculdade de Medicina de ValençaAndréia A Azevedo, M.D., Principal investigator, Otosul -Otorrinolaringologia Sul-Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591994
- Sponsor's protocol ID
- OTOSUL 01/2007
- Other IDs
- FMV 01/2006
- Acronym
- piribedil
- Status last verified
- Dec 2007
- First submitted
- 26 Dec 2007
- Last updated
- 7 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19574947
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography
- ClinicalTrials.gov ID
- NCT00591994
- Acronym / sponsor ID
- piribedil / OTOSUL 01/2007
- Conditions
- Tinnitus
- Keywords
- tinnitus, piribedil, acoustic otoemissions, ECoG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Faculdade de Medicina de ValencaUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Dec 2007 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- tinnitus for more than 6 months
- THI > 38
- no central acting drugs in the last 6 months
- tympanogram type A-n
Key exclusion criteria (4 listed)
- vascular and muscular tinnitus
- concomitant TMJ disorders
- abnormal otoscopy
- mixed and conductive hearing losses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| piribedil50 mg once a day, after lunch 3 month therapy | Drug | – |
Primary outcome
THI - Tinnitus Handicap Inventory
Time frame: Months 3 and 6
1 secondary outcome
VAS - Visual Analog Scale
Time frame: Months 3 and 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2008.
- Derived from this study: PubMed 19574947de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo R Figueiredo, M.D.,M.Sc study chair
Faculdade de Medicina de Valença
Andréia A Azevedo, M.D. principal investigator
Otosul -Otorrinolaringologia Sul-Fluminense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing piribedil in people with Tinnitus, run by Faculdade de Medicina de Valenca at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THI - Tinnitus Handicap Inventory (time frame: Months 3 and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00591994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2008; AzTrials last refreshed its copy on 8 Nov 2026.