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ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin

NCT06521190 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-09-19

No results posted yet for this study

Summary

Randomized, double-blind, placebo-controlled, multicenter phase IIa clinical trial in adult male TCa patients with the risk to suffer from sensorineural hearing loss (SNHL) due to cisplatin therapy within a chemotherapeutic regimen of testicular cancer. Patients will have an indication for a cisplatin-containing chemotherapy according to current guidelines and trial site tumor board recommendations. The trial is designed to show efficacy, safety, and tolerability of ACOU085 administered into the middle ear using 3 transtympanic injections per ear prior to 3 planned and corresponding 3-week chemotherapeutic cycles. The intra-individual control will be done by placebo injection into the respective contralateral middle ear.

Conditions

  • Cisplatin-induced Hearing Loss

Interventions

DRUG

ACOU085 (bimokalner)

Transtympanic injection

DRUG

Placebo

Transtympanic injection

Sponsors & Collaborators

  • Acousia Therapeutics GmbH

    lead INDUSTRY

Principal Investigators

  • Sven Becker, PD Dr. · Dept. of Otolaryngology - Head and Neck Surgery, Tübingen University, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2025-03-31
Completion
2025-09-30

Countries

  • Germany

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06521190 on ClinicalTrials.gov