Trial Outcomes & Findings for SPI-1005 for the Treatment of Meniere's Disease (NCT NCT04677972)
NCT ID: NCT04677972
Last Updated: 2026-07-23
Results Overview
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
220 participants
Primary outcome timeframe
84 days
Results posted on
2026-07-23
Participant Flow
Participant milestones
| Measure |
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
Placebo
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
|---|---|---|
|
Randomized Controlled Trial (RCT)
STARTED
|
112
|
108
|
|
Randomized Controlled Trial (RCT)
COMPLETED
|
106
|
105
|
|
Randomized Controlled Trial (RCT)
NOT COMPLETED
|
6
|
3
|
|
Open Label Extension (OLE)
STARTED
|
197
|
0
|
|
Open Label Extension (OLE)
Day 180 (6-months treatment)
|
153
|
0
|
|
Open Label Extension (OLE)
Day 360 (12-months treatment)
|
89
|
0
|
|
Open Label Extension (OLE)
COMPLETED
|
125
|
0
|
|
Open Label Extension (OLE)
NOT COMPLETED
|
72
|
0
|
Reasons for withdrawal
| Measure |
SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
Placebo
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
|---|---|---|
|
Randomized Controlled Trial (RCT)
Adverse Event
|
1
|
0
|
|
Randomized Controlled Trial (RCT)
Withdrawal by Subject
|
1
|
0
|
|
Randomized Controlled Trial (RCT)
Protocol Violation
|
4
|
3
|
|
Open Label Extension (OLE)
Withdrawal by Subject
|
36
|
0
|
|
Open Label Extension (OLE)
Protocol Violation
|
26
|
0
|
|
Open Label Extension (OLE)
Lost to Follow-up
|
6
|
0
|
|
Open Label Extension (OLE)
Physician Decision
|
2
|
0
|
|
Open Label Extension (OLE)
Adverse Event
|
2
|
0
|
Baseline Characteristics
SPI-1005 for the Treatment of Meniere's Disease
Baseline characteristics by cohort
| Measure |
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 11.55 • n=9 Participants
|
56.8 years
STANDARD_DEVIATION 10.58 • n=27 Participants
|
55.7 years
STANDARD_DEVIATION 11.12 • n=267 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=9 Participants
|
55 Participants
n=27 Participants
|
101 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=9 Participants
|
53 Participants
n=27 Participants
|
119 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=9 Participants
|
103 Participants
n=27 Participants
|
211 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
97 Participants
n=9 Participants
|
102 Participants
n=27 Participants
|
199 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
112 participants
n=9 Participants
|
108 participants
n=27 Participants
|
220 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: 84 daysNumber of Participants with Treatment-Emergent Adverse Events (TEAEs)
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events
Total Number of Patients with Treatment Emergent Adverse Events (TEAE)
|
45 Participants
|
59 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Number of Patients with Mild TEAE
|
17 Participants
|
32 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Number of Patients with Moderate TEAE
|
26 Participants
|
23 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events
Number of Patients with Severe TEAE
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 84 daysCo-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000Hz)
|
40 Participants
|
59 Participants
|
|
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Threshold Improvement from Baseline >=10 dB in 2 adjacent low frequencies (250, 500, or 1000Hz)
|
16 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: 84 daysCo-primary efficacy endpoint; assessment of speech discrimination by Words-in-Noise (WIN) Test (WIN Score Improvement from Baseline \>=4 words) The Words-in-Noise (WIN) test is a speech discrimination test which involves the presentation of specific words against a background noise (multi-talker babble). A total of 35 words are presented to each ear, with 5 words presented at each of 7 different signal-to-noise ratios representing increasing difficulty as the test progresses. The WIN Score is the sum total number of words correct (minimum 0, maximum 35) for each ear. A higher WIN Score is considered to be a better outcome. A WIN Score Improvement is an increase in score from baseline. The co-primary efficacy endpoint is the number of participants who had a WIN Score Improvement from Baseline of \>=4 words out of the maximum of 35 words, in one or both ears.
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Change in Words-in-Noise Test Score
|
30 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 84 daysTinnitus Functional Index (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Change in Tinnitus Severity
|
-6.6 scores on a scale
Standard Deviation 16.15
|
-7.9 scores on a scale
Standard Deviation 20.42
|
SECONDARY outcome
Timeframe: 84 daysTinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Change in Tinnitus Loudness
|
-0.9 scores on a scale
Standard Deviation 2.16
|
-0.8 scores on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: 84 daysVertigo Symptom Scale (0-60) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Change in Vertigo Severity
|
-0.1 scores on a scale
Standard Deviation 1.43
|
-0.3 scores on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: 84 daysAural Fullness Scale (0-10) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Change in Aural Fullness
|
-0.6 scores on a scale
Standard Deviation 2.65
|
-1.2 scores on a scale
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: 84 daysDizziness Handicap Inventory (0-100) where higher score is worse outcome. Mean change from baseline is reported, where a decrease in score is a better outcome.
Outcome measures
| Measure |
Placebo
n=108 Participants
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
SPI-1005 400 mg BID
n=112 Participants
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|
|
Change in Dizziness
|
-6.1 scores on a scale
Standard Deviation 14.88
|
-5.9 scores on a scale
Standard Deviation 14.71
|
Adverse Events
SPI-1005 400 mg BID
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Open Label Extension: SPI-1005 400 mg BID
Serious events: 4 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPI-1005 400 mg BID
n=112 participants at risk
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
Placebo
n=108 participants at risk
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
Open Label Extension: SPI-1005 400 mg BID
n=197 participants at risk
Oral administration of SPI-1005 400 mg BID for up to 360 days
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.89%
1/112 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/197 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Infections and infestations
Diverticulitis
|
0.89%
1/112 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/197 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/112 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.51%
1/197 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/112 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.51%
1/197 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/112 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.51%
1/197 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/112 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.51%
1/197 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/112 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.51%
1/197 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
Other adverse events
| Measure |
SPI-1005 400 mg BID
n=112 participants at risk
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Ebselen: Glutathione peroxidase mimetic
|
Placebo
n=108 participants at risk
Oral administration of matching placebo BID for 28 days, with 84-day followup
Placebo: Matching placebo containing excipients
|
Open Label Extension: SPI-1005 400 mg BID
n=197 participants at risk
Oral administration of SPI-1005 400 mg BID for up to 360 days
Ebselen: Glutathione peroxidase mimetic
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
9.8%
11/112 • Number of events 15 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
8.3%
9/108 • Number of events 10 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
12.7%
25/197 • Number of events 40 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Ear and labyrinth disorders
Tinnitus
|
8.9%
10/112 • Number of events 10 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
6.5%
7/108 • Number of events 7 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
11.7%
23/197 • Number of events 25 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Investigations
Alanine aminotransferase increased
|
0.89%
1/112 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
10.2%
11/108 • Number of events 11 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
16.2%
32/197 • Number of events 36 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
3.6%
4/112 • Number of events 6 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
5.6%
6/108 • Number of events 8 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
7.1%
14/197 • Number of events 14 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.89%
1/112 • Number of events 1 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
5.6%
6/108 • Number of events 6 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
10.7%
21/197 • Number of events 22 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Infections and infestations
COVID-19
|
2.7%
3/112 • Number of events 3 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
2.8%
3/108 • Number of events 3 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
9.1%
18/197 • Number of events 18 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Nervous system disorders
Dizziness
|
3.6%
4/112 • Number of events 4 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
0.00%
0/108 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
6.6%
13/197 • Number of events 14 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
3.6%
4/112 • Number of events 4 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
1.9%
2/108 • Number of events 4 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
5.1%
10/197 • Number of events 12 • SPI-1005 400 mg BID & Placebo: 3 months Open Label Extension: SPI-1005 400 mg BID: 6 to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI will not, during or subsequent to the term of the Clinical Trial Agreement, use Confidential Information for any purpose whatsoever other than the performance of the Services, and will not disclose Confidential Information to any third party. Confidential Information will remain the sole property of Sponsor, as applicable.
- Publication restrictions are in place
Restriction type: OTHER