NCT06521190

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Acousia Therapeutics GmbH · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ACOU085 (bimokalner)	Transtympanic injection
DRUG	Placebo	Transtympanic injection

Timeline

• Start date: 2023-12-15
• Primary completion: 2025-03-31
• Completion: 2025-09-30
• First posted: 2024-07-25
• Last updated: 2024-09-19

Locations

10 sites across 1 country: Germany