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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of Southern California
Los Angeles, California, United States
House Clinic
Los Angeles, California, United States
Number of Participants With Treatment-Emergent Adverse Events
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: 84 days
Change in Low Frequency Hearing Thresholds Measured by Pure Tone Audiometry
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Time frame: 84 days
Change in Words-in-Noise Test Score
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.
Time frame: 84 days
Change in Tinnitus Severity
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.
Time frame: 84 days
Change in Tinnitus Loudness
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.
Time frame: 84 days
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Sacramento Ear, Nose, & Throat
Roseville, California, United States
George Washington University
Washington D.C., District of Columbia, United States
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Piedmont Ear, Nose & Throat Associates
Winston-Salem, North Carolina, United States
...and 2 more locations
Change in Vertigo Severity
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.
Time frame: 84 days
Change in Aural Fullness
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.
Time frame: 84 days
Change in Dizziness
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.
Time frame: 84 days