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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)
Director
Otorhinolaryngology Department
Navarre headquarters
Status
In recruitment
headquarters
Pamplona/Madrid
Technical Summary
- 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.
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