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Trial Outcomes & Findings for SPI-1005 for the Treatment of Patients With Meniere's Disease (NCT NCT03325790)

NCT ID: NCT03325790

Last Updated: 2023-09-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

149 participants

Primary outcome timeframe

8 weeks

Results posted on

2023-09-18

Participant Flow

Participants underwent screening procedures, including audiometric evaluation, to ensure they met inclusion/exclusion criteria prior to assignment to a treatment group. 20 patients were screen failures due to not meeting specific inclusion/exclusion criteria. 3 patients were eligible for the study and were assigned to an arm/group but did not start treatment.

Participant milestones

Participant milestones
Measure
Placebo
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Overall Study
STARTED
42
42
42
Overall Study
COMPLETED
41
41
38
Overall Study
NOT COMPLETED
1
1
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SPI-1005 for the Treatment of Patients With Meniere's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo
n=42 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=42 Participants
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Total
n=126 Participants
Total of all reporting groups
Age, Continuous
55.1 years
STANDARD_DEVIATION 13.03 • n=99 Participants
55.9 years
STANDARD_DEVIATION 9.55 • n=107 Participants
50.6 years
STANDARD_DEVIATION 10.55 • n=206 Participants
53.9 years
STANDARD_DEVIATION 11.30 • n=7 Participants
Sex: Female, Male
Female
20 Participants
n=99 Participants
26 Participants
n=107 Participants
20 Participants
n=206 Participants
66 Participants
n=7 Participants
Sex: Female, Male
Male
22 Participants
n=99 Participants
16 Participants
n=107 Participants
22 Participants
n=206 Participants
60 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=99 Participants
7 Participants
n=107 Participants
4 Participants
n=206 Participants
14 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants
n=99 Participants
35 Participants
n=107 Participants
38 Participants
n=206 Participants
112 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
Race (NIH/OMB)
Asian
2 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
2 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
5 Participants
n=7 Participants
Race (NIH/OMB)
White
39 Participants
n=99 Participants
37 Participants
n=107 Participants
39 Participants
n=206 Participants
115 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
3 Participants
n=7 Participants
Region of Enrollment
United States
42 participants
n=99 Participants
42 participants
n=107 Participants
42 participants
n=206 Participants
126 participants
n=7 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Placebo
n=42 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=42 Participants
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of Patients with Mild TEAE
15 Participants
18 Participants
18 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of Patients with Moderate TEAE
6 Participants
3 Participants
7 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of Patients with Severe TEAE
0 Participants
0 Participants
2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Total Number of Patients with Treatment Emergent Adverse Events (TEAE)
19 Participants
20 Participants
20 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry

Outcome measures

Outcome measures
Measure
Placebo
n=41 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=41 Participants
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Efficacy of SPI-1005 on Hearing Loss
Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz) · Yes
8 Participants
7 Participants
15 Participants
Efficacy of SPI-1005 on Hearing Loss
Threshold Improvement >=10 dB in 2 adjacent low frequencies (250 and 500 Hz, or 500 and 1000 Hz) · No
33 Participants
35 Participants
25 Participants
Efficacy of SPI-1005 on Hearing Loss
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz) · Yes
15 Participants
16 Participants
25 Participants
Efficacy of SPI-1005 on Hearing Loss
Threshold Improvement from Baseline >=10 dB in at least 1 low frequency (250, 500, or 1000 Hz) · No
26 Participants
26 Participants
16 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

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.

Outcome measures

Outcome measures
Measure
Placebo
n=41 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=41 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=40 Participants
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Efficacy of SPI-1005 on Word Recognition Score
WIN Score Improvement from Baseline >=10% · Yes
23 Participants
23 Participants
30 Participants
Efficacy of SPI-1005 on Word Recognition Score
WIN Score Improvement from Baseline >=10% · No
18 Participants
18 Participants
10 Participants
Efficacy of SPI-1005 on Word Recognition Score
WIN Score Improvement from Baseline >=20% · Yes
19 Participants
17 Participants
27 Participants
Efficacy of SPI-1005 on Word Recognition Score
WIN Score Improvement from Baseline >=20% · No
22 Participants
24 Participants
13 Participants
Efficacy of SPI-1005 on Word Recognition Score
WIN Score Improvement from Baseline >= 4 words · Yes
14 Participants
13 Participants
24 Participants
Efficacy of SPI-1005 on Word Recognition Score
WIN Score Improvement from Baseline >= 4 words · No
27 Participants
28 Participants
16 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

Improvement in the Tinnitus Functional Index (TFI) from baseline. TFI Total Score: 0-100, in which a higher score means a worse outcome.

Outcome measures

Outcome measures
Measure
Placebo
n=41 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=41 Participants
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Efficacy of SPI-1005 on Tinnitus
TFI Total Score >= 10pt. reduction from Baseline
20 Participants
19 Participants
13 Participants
Efficacy of SPI-1005 on Tinnitus
No TFI Total Score >= 10pt. reduction from Baseline
21 Participants
23 Participants
28 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

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.

Outcome measures

Outcome measures
Measure
Placebo
n=41 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=41 Participants
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Efficacy of SPI-1005 on Tinnitus Loudness
TL >= 2pt. reduction from Baseline
14 Participants
15 Participants
14 Participants
Efficacy of SPI-1005 on Tinnitus Loudness
No TL >= 2pt. reduction from Baseline
27 Participants
27 Participants
27 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Analysis population includes those participants who completed the outcome measure at baseline and 8-week follow-up.

Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome

Outcome measures

Outcome measures
Measure
Placebo
n=41 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=41 Participants
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Efficacy of SPI-1005 on Vertigo
VSS Total Scale >= 6pt. reduction from Baseline
21 Participants
21 Participants
18 Participants
Efficacy of SPI-1005 on Vertigo
No VSS Total Scale >= 6pt. reduction from Baseline
20 Participants
21 Participants
23 Participants

SECONDARY outcome

Timeframe: 2 weeks, 4 weeks, 8 weeks

Population: 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.

Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals

Outcome measures

Outcome measures
Measure
Placebo
n=42 Participants
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 Participants
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Trough Plasma Concentration of SPI-1005
2 weeks
27.2 ng/mL
Standard Deviation 19.8
48.4 ng/mL
Standard Deviation 33.2
—
Trough Plasma Concentration of SPI-1005
4 weeks
19.7 ng/mL
Standard Deviation 14.7
40.6 ng/mL
Standard Deviation 29.1
—
Trough Plasma Concentration of SPI-1005
8 weeks
0 ng/mL
Standard Deviation 0
0 ng/mL
Standard Deviation 0
—

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

200mg SPI-1005 Twice Daily (BID)

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

400mg SPI-1005 BID

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo
n=42 participants at risk
Placebo Placebo: Placebo Comparator
200mg SPI-1005 Twice Daily (BID)
n=42 participants at risk
200mg SPI-1005 BID 200mg SPI-1005 BID: Active: low dose
400mg SPI-1005 BID
n=42 participants at risk
400mg SPI-1005 BID 400mg SPI-1005 BID: Active: high dose
Infections and infestations
Upper respiratory tract infection
2.4%
1/42 • Number of events 1 • 8 weeks
4.8%
2/42 • Number of events 2 • 8 weeks
9.5%
4/42 • Number of events 4 • 8 weeks
Investigations
Alanine aminotransferase increased
0.00%
0/42 • 8 weeks
7.1%
3/42 • Number of events 3 • 8 weeks
9.5%
4/42 • Number of events 4 • 8 weeks
Investigations
Blood triglycerides increased
2.4%
1/42 • Number of events 1 • 8 weeks
11.9%
5/42 • Number of events 5 • 8 weeks
2.4%
1/42 • Number of events 1 • 8 weeks
Investigations
Gamma-glutamyltransferase increased
2.4%
1/42 • Number of events 1 • 8 weeks
7.1%
3/42 • Number of events 3 • 8 weeks
0.00%
0/42 • 8 weeks

Additional Information

Dr. Jonathan Kil

Sound Pharmaceuticals, Inc.

Phone: 206-634-2559

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