Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
A legfontosabb adatok
- Fázis
- 2. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
7 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálat adatai
- Ki végzi
- AudioCure Pharma GmbH
- Azonosító
- NCT05776459EU 2024-513658-31-00
- A regiszteradat frissítve
- 2026. november 4.
- Eredeti leírás
The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).A teljes eredeti leírásKevesebb
Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss
The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).
Bevonási feltételek: Male or female patients aged between 18 and 85 years; Unilateral ISSNHL; Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization; An absolute air conduction hearing threshold of at least 65 dB,; Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear.
Kizáró feltételek: History of ISSNHL in the past 1 years in the affected ear; Insufficient handling of the language used in the speech audiometry tests; Bilateral hearing loss; Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time; Congenital hearing loss; Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB.