RecruitingPhase 2NCT06521190

ACOU085 for Hearing Loss Prevention in Testicular Cancer Patients Receiving Cisplatin

Phase IIa Randomized, Double-blind, and Placebo-controlled Multicenter Split Body Trial of Repeated Doses of ACOU085 for the Prevention of Hearing Loss in Testicular Cancer Patients Receiving Cisplatin

Sponsor

Acousia Therapeutics GmbH

Enrollment

40 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

Cisplatin-induced Hearing Loss

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.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a drug called ACOU085 (taken as ear drops) can protect hearing in young men with testicular cancer who are receiving cisplatin chemotherapy, which is known to cause hearing loss. **You may be eligible if...** - You are a male between 18 and 45 years old - You have testicular cancer and are scheduled for cisplatin chemotherapy at a total dose of at least 300 mg/m² over 3 cycles - You currently have normal hearing in both ears (confirmed by hearing tests) - Your heart, blood pressure, and lab values are within normal limits - You agree to use two forms of contraception for 6 months after the trial starts - You are able to understand and communicate in German **You may NOT be eligible if...** - You have a genetic condition associated with hearing loss - You have a history of ear surgery, chronic ear infections, or Meniere's disease - You already have hearing loss in either ear - You have radiation-induced hearing loss or other inner ear conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGACOU085 (bimokalner)

Transtympanic injection

DRUGPlacebo

Transtympanic injection

Locations(10)

Dept. of Otolaryngology - Head and Neck Surgery, Tuebingen University

Tübingen, Baden-Wurttemberg, Germany

Dept. of Otolaryngology - Head and Neck Surgery, Dresden University

Dresden, Germany

Dept. of Otolaryngology - Head and Neck Surgery, Essen University

Essen, Germany

Department of Otolaryngology - Head and Neck Surgery, Hamburg University

Hamburg, Germany

Dept. of Otolaryngology - Head and Neck Surgery, Jena University

Jena, Germany

Dept. of Otolaryngology - Head and Neck Surgery, Mannheim University

Mannheim, Germany

Dept. of Otolaryngology - Head and Neck Surgery, Marburg University

Marburg, Germany

Dept. of Hematology and Oncology, Rotkreuzklinikum Munich

Munich, Germany

Dept. of Otolaryngology - Head and Neck Surgery, Munich Technical University

Munich, Germany

Dept. of Otolaryngology - Head and Neck Surgery, Wuerzburg University

Würzburg, Germany

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NCT06521190