Trial · NCT06340633
SPI-1005 in Adults Receiving Cochlear Implant
NCT06340633, Phase 2, Recruiting, Sound Pharmaceuticals, Incorporated
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SPI-1005 in Adults Receiving Cochlear Implant. Trials, record NCT06340633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06340633
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPI-1005 in Adults Receiving Cochlear Implant
- NCT number
- NCT06340633
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Conditions
- Hearing Loss, Cochlear Trauma
- Interventions
- Ebselen, Placebo
- First posted
- 2024-04-01
- Last updated
- 2026-06-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Treatment Emergent Adverse Events (TEAE) | 12 months | 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. |
| Other | Effect of SPI-1005 on Residual Low Frequency Hearing | 12 months | Residual hearing at low frequencies (≤1000 Hz) using pure tone audiometry |
| Other | Effect of SPI-1005 on Word Recognition | 12 months | Word recognition using words in quiet |
| Other | Effect of SPI-1005 on Speech Discrimination | 12 months | Speech discrimination using words in noise |
| Other | Effect of SPI-1005 on Tinnitus | 12 months | Tinnitus severity using the Tinnitus Functional Index (TFI). TFI Total Score: 0-100, in which a higher score means a worse outcome. |
| Other | Effect of SPI-1005 on Vertigo | 12 months | Vertigo severity using the Vertigo Symptoms Scale (VSS). VSS Total Scale: 0-60, in which a higher score means a worse outcome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06340633
GET https://conductscience.org/api/trials/v1/NCT06340633/registered