Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Tinnitus Clinical Trial

— piribedil  

Official title:

Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591994
• Other study ID #: OTOSUL 01/2007
• Secondary ID: FMV 01/2006
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: March 6, 2008
• Start date: November 2006

Study information

• Verified date: December 2007
• Source: Faculdade de Medicina de Valenca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• piribedil
50 mg once a day, after lunch 3 month therapy

Locations

Country	Name	City	State
Brazil	OTOSUL,Otorrinolaringologia Sul-Fluminense	Volta Redonda	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Medicina de Valenca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	THI - Tinnitus Handicap Inventory		Months 3 and 6	No
Secondary	VAS - Visual Analog Scale		Months 3 and 6	No

External Links

•   Tinnitus Center homepage