Ménière, Meniere Disease
Conditions
Keywords
ebselen, hearing loss, tinnitus, vertigo, dizziness, SPI-1005
Brief summary
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.
Interventions
DRUGEbselen
Glutathione peroxidase mimetic
DRUGPlacebo
Matching placebo containing excipients
Sponsors
Sound Pharmaceuticals, Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult males/females, 18-75 years of age at the time of enrollment. * Diagnosis of definite Meniere's Disease by AAO-HNS Amended 2015 Criteria. * Hearing loss of ≥30 dB at 250, 500, or 1000 Hz at study enrollment. * At least two of three active symptoms (tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease by AAO-HNS Amended 2015 Criteria, within 3 months of study enrollment.
Exclusion criteria
* Current, or within 60 days prior to study enrollment, use of IV ototoxic medications * History of otosclerosis or vestibular schwannoma. * History of significant middle ear or inner ear surgery in the affected ear. * Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss. * Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, neurological, or psychiatric disease. * Current use or within 30 days prior to study enrollment systemic steroids. * Current use or within 7 days prior to study enrollment intratympanic steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | 84 days | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) |
| Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry | 84 days | Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry |
| Change in Words-in-Noise Test Score | 84 days | Co-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tinnitus Severity | 84 days | Tinnitus 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. |
| Change in Tinnitus Loudness | 84 days | Tinnitus 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. |
| Change in Vertigo Severity | 84 days | Vertigo 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. |
| Change in Aural Fullness | 84 days | Aural 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. |
| Change in Dizziness | 84 days | Dizziness 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 10.58 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 211 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 199 Participants |
| Region of Enrollment United States | 220 participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 108 | 0 / 197 |
| other Total, other adverse events | 25 / 112 | 19 / 108 | 90 / 197 |
| serious Total, serious adverse events | 2 / 112 | 0 / 108 | 4 / 197 |
Outcome results
None listed