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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 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.

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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.

Conditions Studied

Hearing Loss Cochlear Trauma

Interventions

  • DRUG Placebo
  • DRUG Ebselen

Study Locations (1)

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-08
Est. Completion 2025-12
Phase Phase 2

Sponsor

Sound Pharmaceuticals, Incorporated

9 total trials

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What the Registry Record Tells You About NCT06340633

The ClinicalTrials.gov registry entry for NCT06340633 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,120-participant average among 58 other Hearing Loss trials with a reported enrollment target (99% lower). The listed sponsor is Sound Pharmaceuticals, Incorporated, which has 9 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.