NCT07153991

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2021

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2025

Completed
Last Updated

September 4, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

August 20, 2025

Last Update Submit

August 31, 2025

Conditions

Tinnitus

Keywords

tinnitusdonepezil

Outcome Measures

Primary Outcomes (1)

  • tinnitus improvement

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

    3 months

Study Arms (2)

Intervention Group (donepezil)

EXPERIMENTAL

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.

Drug: Donepezil group

Placebo group

PLACEBO COMPARATOR

35 Pacients with tinnitus received for 3 months placebo medication

Drug: Placebo group

Interventions

Donepezil groupDRUG

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

Intervention Group (donepezil)
Placebo groupDRUG

35 Pacients with tinnitus received for 3 months placebo medication

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with chronic sensorineural tinnitus type

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade De São Paulo

São Paulo, São Paulo, 04356080, Brazil

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 4, 2025

Study Start

November 19, 2021

Primary Completion

December 9, 2025

Study Completion

December 9, 2025

Last Updated

September 4, 2025

Record last verified: 2025-08

Locations

BR(1)