A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Megadott ok: Study did not start
A legfontosabb adatok
- Hol
- Charleston, Dallas, Kansas City, Miami és Seattle (Egyesült Államok)Mind a 5 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- MUSCCharleston, Egyesült ÁllamokNo longer taking part
- University of Texas, SouthwesternDallas, Egyesült ÁllamokNo longer taking part
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
- University of MiamiMiami, Egyesült ÁllamokNo longer taking part
- Sound Pharmaceuticals, Inc.Seattle, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Sound Pharmaceuticals, Incorporated
- Azonosító
- NCT02779192
- A regiszteradat frissítve
- 2026. június 3.
- Eredeti leírás
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.A teljes eredeti leírásKevesebb
A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
Bevonási feltételek: Adult male or female patients, 18-50 years of age; History of either recreational and/or occupational exposure to noise; Voluntarily consent to participate in the study; Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or intra-uterine device in place for at least 3 months prior to study through study completion; or barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or stable hormonal contraceptive for at least 3 months prior to study through study completion; or surgical sterilization (vasectomy) of partner at least 6 months prior to study; Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.
Kizáró feltételek: Current use or within 60 days prior to study of excluded ototoxic medications; Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes; Participation in another investigational drug or device study within 90 days prior to study enrollment; History of autoimmune inner ear disease; History of middle ear or inner ear surgery; Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease; History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen; Current conductive hearing loss or middle ear effusion; Female patients who are pregnant or breastfeeding.