drugset / Trial / NCT00591994

Tinnitus Treatment With Piribedil Guided by Acoustic Otoemissions and Electrocochleography

NCT00591994 ↗

Completed 100 enrolled Faculdade de Medicina de Valenca
RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2006-11
Primary completion
2007-12
Completion
—

Outcome

Missed primary endpoint

paper There was no significant improvement of Tinnitus Handicap Inventory and visual analog scale score after piribedil treatment as compared with placebo. PMID 19574947 ↗

paper CONCLUSION: Piribedil is not superior to placebo in the treatment of tinnitus. PMID 19574947 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject piribedil Small molecule 50 mg —

Indications