Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06340633 · ClinicalTrials.gov registry record · Phase 2
SPI-1005 in Adults Receiving Cochlear Implant
A Phase 2 study of Hearing Loss and Cochlear Trauma, sponsored by Sound Pharmaceuticals, Incorporated.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06340633: Recruiting Phase 2 study of Hearing Loss and Cochlear Trauma, sponsored by Sound Pharmaceuticals, Incorporated.
NCT06340633 is a Phase 2 study of Hearing Loss and Cochlear Trauma that is actively recruiting participants, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 40 participants, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06340633, a Phase 2 study of Hearing Loss and Cochlear Trauma, is actively recruiting participants, sponsored by Sound Pharmaceuticals, Incorporated.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ebselen
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-08 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT06340633 shows while recruiting
NCT06340633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Hearing Loss appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06340633 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06340633 about?
NCT06340633 is a clinical study titled "SPI-1005 in Adults Receiving 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...
What is the current status of trial NCT06340633?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-08. Estimated completion is 2025-12.
What conditions does trial NCT06340633 study?
This clinical trial studies the following conditions: Hearing Loss, Cochlear Trauma.
What interventions are being tested in trial NCT06340633?
The interventions under investigation include: Placebo (DRUG), Ebselen (DRUG).
Who is sponsoring clinical trial NCT06340633?
This trial is sponsored by Sound Pharmaceuticals, Incorporated, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06340633 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hearing Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06340633's enrollment target sits among peer trials
40 45th of 58 higher than 12 of 58 other Hearing Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Cholesterol and Antioxidant Treatment in Patients With Smith-Lemli-Opitz Syndrome (SLOS)
RECRUITING · Phase 2
-
Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer
RECRUITING · Phase 2
-
Quantifying Auditory Perceptual Learning Following Hearing Aid Fitting
COMPLETED · Phase 2
-
Improving Access and Affordability of Adult Hearing Healthcare
RECRUITING · NA
-
AI Noise Reduction in Phonak Hearing Aids
RECRUITING · NA
-
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia