SPI-1005 in Adults Receiving Cochlear Implant
A legfontosabb adatok
- Hol
- Charleston, Columbus, Dallas, Iowa City, Milwaukee és Philadelphia (Egyesült Államok)Mind a 6 helyszín megnézése
- Fázis
- 2. fázis
Helyszínek itt: Egyesült Államok
- Medical University of South CarolinaCharleston, Egyesült ÁllamokContact: Research DirectorRésztvevőt keres
- Ohio State UniversityColumbus, Egyesült ÁllamokContact: Beth Miles-MarkleyRésztvevőt keres
- University of Texas, SouthwesternDallas, Egyesült ÁllamokContact: Paula Arellano-CruzRésztvevőt keres
- University of IowaIowa City, Egyesült ÁllamokContact: Lead Clinical Research CoordinatorRésztvevőt keres
- Medical College of WisconsinMilwaukee, Egyesült ÁllamokContact: Clinical Research CoordinatorToborzás még nem indult
- Thomas Jefferson UniversityPhiladelphia, Egyesült ÁllamokContact: Morgan KyserRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Sound Pharmaceuticals, Incorporated
- Azonosító
- NCT06340633
- A regiszteradat frissítve
- 2026. június 26.
- Eredeti leírás
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.A teljes eredeti leírásKevesebb
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant
The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.
The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might participants experience when taking drug SPI-1005?
The clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.
Participants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.
The effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.
Bevonási feltételek: Adults who are ≥18 years of age at time of consent; Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear; Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:; ≤70 dB HL at 125, 250, and 500 Hz; AND; ≥70 dB HL at 2000, 4000, and 8000 Hz; Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant; Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.
Kizáró feltételek: Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide; Participation in another investigational drug or device study within 90 days prior to study consent; No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant; Moderate or severe hepatic impairment using Child-Pugh Score (>6 points); Female patients who are pregnant or breastfeeding; No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).