Efficacy of Donepezil in Patients With Chronic Tinnitus

University of Sao Paulo

Status and phase: Active, not recruiting; Phase 4

Conditions: Tinnitus

Treatments: Drug: Donepezil group; Drug: Placebo group

Study type: Interventional

Funder types: Other

Identifiers

NCT07153991

CAAE 34251320.5.0000.0068

U1111-1248-6988 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with chronic sensorineural tinnitus type

Exclusion criteria

• pregnancy, arrhythmia, donepezil allergy, yelow dye allergy, otitis or any ear inflamatory diseases, patients taking any medication for dementia, convulsive diseases, asthma, patients taking any of these medications: carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin, ketoconazole, quinidine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Intervention Group (donepezil)

Experimental group

Description:

35 Participants with tinnitus received donepezil for 3 months, starting with 5 mg daily for the first month and 10 mg daily for the following two months.

Treatment:

Drug: Donepezil group

Placebo group

Placebo Comparator group

Description:

35 Pacients with tinnitus received for 3 months placebo medication

Treatment:

Drug: Placebo group