SPI-1005 for the Treatment of Meniere's Disease
A legfontosabb adatok
- Hol
- Boca Raton, Charleston, Indianapolis, Kansas City, Little Rock, Los Angeles, Louisville, Philadelphia, Roseville, Washington D.C. és Winston-Salem (Egyesült Államok)Mind a 12 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- ENT and Allergy Associates of FloridaBoca Raton, Egyesült ÁllamokNo longer taking part
- Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- Indiana UniversityIndianapolis, Egyesült ÁllamokNo longer taking part
- Kansas University Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
- University of Arkansas for Medical SciencesLittle Rock, Egyesült ÁllamokNo longer taking part
- House ClinicLos Angeles, Egyesült ÁllamokNo longer taking part
- University of Southern CaliforniaLos Angeles, Egyesült ÁllamokNo longer taking part
- Advanced ENT & AllergyLouisville, Egyesült ÁllamokNo longer taking part
- Thomas Jefferson UniversityPhiladelphia, Egyesült ÁllamokNo longer taking part
- Sacramento Ear, Nose, & ThroatRoseville, Egyesült ÁllamokNo longer taking part
- George Washington UniversityWashington D.C., Egyesült ÁllamokNo longer taking part
- Piedmont Ear, Nose & Throat AssociatesWinston-Salem, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Sound Pharmaceuticals, Incorporated
- Azonosító
- NCT04677972
- A regiszteradat frissítve
- 2026. július 23.
- Eredeti leírás
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.A teljes eredeti leírásKevesebb
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.
Bevonási feltételek: Adult males/females, 18-75 years of age at the time of enrollment; Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria; Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment; At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.
Kizáró feltételek: Current, or within 60 days prior to study enrollment, use of IV ototoxic medications; Current use or within 30 days prior to study enrollment systemic steroids; Current use or within 7 days prior to study enrollment intratympanic steroids; History of otosclerosis or vestibular schwannoma; History of significant middle ear or inner ear surgery in the affected ear; Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease; Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.