Trial · NCT03325790
SPI-1005 for the Treatment of Patients With Meniere's Disease
NCT03325790, Phase 2, Completed, Sound Pharmaceuticals, Incorporated; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SPI-1005 for the Treatment of Patients With Meniere's Disease. Trials, record NCT03325790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03325790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPI-1005 for the Treatment of Patients With Meniere's Disease
- NCT number
- NCT03325790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 149 participants, actual
- Lead sponsor
- Sound Pharmaceuticals, Incorporated
- Conditions
- Meniere's Disease
- Interventions
- 200mg SPI-1005 BID, 400mg SPI-1005 BID, Placebo
- First posted
- 2017-10-30
- Last updated
- 2023-09-18
- Results first posted
- 2023-08-14
Source ClinicalTrials.gov
Registered outcomes7
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) | 8 weeks | 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. |
| Primary | Efficacy of SPI-1005 on Hearing Loss | 8 weeks | Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry |
| Primary | Efficacy of SPI-1005 on Word Recognition Score | 8 weeks | Improvement in Words-in-Noise (WIN) test score from baseline. WIN test score, 0-35 words, in which a higher score means a better outcome. |
| Primary | Efficacy of SPI-1005 on Tinnitus | 8 weeks | Improvement in the Tinnitus Functional Index (TFI) from baseline. TFI Total Score: 0-100, in which a higher score means a worse outcome. |
| Primary | Efficacy of SPI-1005 on Tinnitus Loudness | 8 weeks | Improvement in Tinnitus Loudness (TL) on response to Tinnitus Functional Index Question Number 2. Question Number 2: "How Strong or Loud is your tinnitus?": 0-10, in which a higher score means a worse outcome. |
| Primary | Efficacy of SPI-1005 on Vertigo | 8 weeks | Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome |
| Secondary | Trough Plasma Concentration of SPI-1005 | 2 weeks, 4 weeks, 8 weeks | Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAE) | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Efficacy of SPI-1005 on Hearing Loss | 8 weeks | Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy of SPI-1005 on Word Recognition Score | 8 weeks | Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy of SPI-1005 on Tinnitus | 8 weeks | Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy of SPI-1005 on Tinnitus Loudness | 8 weeks | Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy of SPI-1005 on Vertigo | 8 weeks | Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Trough Plasma Concentration of SPI-1005 | 2 weeks, 4 weeks, 8 weeks | In the placebo group, all ebselen concentrations were below the limit of quantitation at all timepoints studied. Therefore, the Analysis Population only includes the SPI-1005 groups. | ng/mL | MEAN |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | Placebo | Total Number of Patients with Treatment Emergent Adverse Events (TEAE) | 19 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | 200mg SPI-1005 Twice Daily (BID) | Total Number of Patients with Treatment Emergent Adverse Events (TEAE) | 20 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | 400mg SPI-1005 BID | Total Number of Patients with Treatment Emergent Adverse Events (TEAE) | 20 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | Placebo | Number of Patients with Mild TEAE | 15 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | 200mg SPI-1005 Twice Daily (BID) | Number of Patients with Mild TEAE | 18 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | 400mg SPI-1005 BID | Number of Patients with Mild TEAE | 18 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | Placebo | Number of Patients with Moderate TEAE | 6 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | 200mg SPI-1005 Twice Daily (BID) | Number of Patients with Moderate TEAE | 3 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | 400mg SPI-1005 BID | Number of Patients with Moderate TEAE | 7 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAE) | Placebo | Number of Patients with Severe TEAE | 0 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | STARTED | 200mg SPI-1005 Twice Daily (BID) | 42 | |
| Overall Study | STARTED | 400mg SPI-1005 BID | 42 | |
| Overall Study | COMPLETED | Placebo | 41 | |
| Overall Study | COMPLETED | 200mg SPI-1005 Twice Daily (BID) | 41 | |
| Overall Study | COMPLETED | 400mg SPI-1005 BID | 38 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | 200mg SPI-1005 Twice Daily (BID) | 1 | |
| Overall Study | NOT COMPLETED | 400mg SPI-1005 BID | 4 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 1 | 42 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | 200mg SPI-1005 Twice Daily (BID) | 2 | 42 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | 400mg SPI-1005 BID | 4 | 42 | 4 |
| other | Alanine aminotransferase increased | Investigations | Placebo | 0 | 42 | 0 |
| other | Alanine aminotransferase increased | Investigations | 200mg SPI-1005 Twice Daily (BID) | 3 | 42 | 3 |
| other | Alanine aminotransferase increased | Investigations | 400mg SPI-1005 BID | 4 | 42 | 4 |
| other | Blood triglycerides increased | Investigations | Placebo | 1 | 42 | 1 |
| other | Blood triglycerides increased | Investigations | 200mg SPI-1005 Twice Daily (BID) | 5 | 42 | 5 |
| other | Blood triglycerides increased | Investigations | 400mg SPI-1005 BID | 1 | 42 | 1 |
| other | Gamma-glutamyltransferase increased | Investigations | Placebo | 1 | 42 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 42 |
| Total, all-cause mortality | 200mg SPI-1005 Twice Daily (BID) | 0 | 42 |
| Total, all-cause mortality | 400mg SPI-1005 BID | 0 | 42 |
| Total, other adverse events | Placebo | 3 | 42 |
| Total, other adverse events | 200mg SPI-1005 Twice Daily (BID) | 7 | 42 |
| Total, other adverse events | 400mg SPI-1005 BID | 8 | 42 |
| Total, serious adverse events | Placebo | 0 | 42 |
| Total, serious adverse events | 200mg SPI-1005 Twice Daily (BID) | 0 | 42 |
| Total, serious adverse events | 400mg SPI-1005 BID | 0 | 42 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT03325790
GET https://conductscience.org/api/trials/v1/NCT03325790/results?page=2