Get to know our clinical trials
Clinical trial to evaluate the safety, tolerability and efficacy of DB-OTO in infants and children
THE MAIN OBJECTIVE OF THE STUDY IS TO: - TO KNOW THE SAFETY OF DB-OTO; - TO DETERMINE HOW WELL DB-OTO IS TOLERATED (DOES NOT CAUSE ONGOING DISCOMFORT); - TO EVALUATE THE EFFICACY OF DB-OTO (THE OUTCOME OF DB-OTO)
- PHASE I/II, OPEN-LABEL, MULTICENTER TRIAL WITH A SINGLE ASCENDING DOSE COHORT WITH UNILATERAL INTRACOCHLEAR INJECTION FOLLOWED BY AN EXTENSION COHORT WITH BILATERAL INJECTION TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF DB-OTO IN CHILDREN AND INFANTS WITH BI-ALLELIC HOTOF MUTATIONS
- Code EudraCT: 2022-000079-38
- Protocol number: DB-OTO-001
- Promoter: Decibel Therapeutics, Inc
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
Do you want to participate in this trial?
Request an appointment for our specialists to assess whether you qualify for this clinical trial
Do you prefer to send us your reports?
If you prefer, you can send us your medical information and our specialists will evaluate your case without the need to come to the Clinica.