Condition: Cisplatin-induced Hearing Loss · Sponsor: Acousia Therapeutics GmbH
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.
This description comes directly from the study's public registry record.
Tim P Boelke, MD · +491705670279 · boelke@acousia.com
Always discuss trial participation with your own doctor first.
| Dept. of Otolaryngology - Head and Neck Surgery, Tuebingen University | Tübingen, Baden-Wurttemberg, Germany | Recruiting |
| Dept. of Otolaryngology - Head and Neck Surgery, Dresden University | Dresden, Germany | Recruiting |
| Dept. of Otolaryngology - Head and Neck Surgery, Essen University | Essen, Germany | Recruiting |
| Department of Otolaryngology - Head and Neck Surgery, Hamburg University | Hamburg, Germany | Recruiting |
| Dept. of Otolaryngology - Head and Neck Surgery, Jena University | Jena, Germany | Recruiting |
| Dept. of Otolaryngology - Head and Neck Surgery, Mannheim University | Mannheim, Germany | Recruiting |
| Dept. of Otolaryngology - Head and Neck Surgery, Marburg University | Marburg, Germany | Recruiting |
| Dept. of Hematology and Oncology, Rotkreuzklinikum Munich | Munich, Germany | Recruiting |
| Dept. of Otolaryngology - Head and Neck Surgery, Munich Technical University | Munich, Germany | Recruiting |
| Dept. of Otolaryngology - Head and Neck Surgery, Wuerzburg University | Würzburg, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06521190