NCT07153991

Efficacy of Donepezil in Patients With Chronic Tinnitus

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, placebo-controlled, randomized, double-blind clinical trial, including 70 patients with chronic sensorineural tinnitus, divided into placebo and treatment groups. Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months.

Detailed description

Treatment effects were monitored using the Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS).

Conditions

• Tinnitus

Interventions

Type	Name	Description
DRUG	Donepezil group	Participants received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months
DRUG	Placebo group	35 Pacients with tinnitus received for 3 months placebo medication

Timeline

• Start date: 2021-11-19
• Primary completion: 2025-12-09
• Completion: 2025-12-09
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study