Clinical trial NCT04677972: SPI-1005 for the Treatment of Meniere's Disease
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meniere Disease
Ménière
Keywords: ebselen
hearing loss
tinnitus
vertigo
dizziness
SPI-1005
Lead sponsor: Sound Pharmaceuticals, Incorporated
Sponsor class: INDUSTRY
First posted: 2020-12-21
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 84 days
measure: Change in low frequency hearing thresholds measured by pure tone audiometry
timeFrame: 56 days
measure: Change in Words-in-Noise Test score
timeFrame: 56 days
Secondary outcomes:
measure: Change in tinnitus severity
timeFrame: 56 days
measure: Change in tinnitus loudness
timeFrame: 56 days
measure: Change in vertigo severity
timeFrame: 56 days
measure: Change in aural fullness
timeFrame: 56 days
measure: Change in dizziness
timeFrame: 56 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: House Clinic
state: California
city: Roseville
country: United States
facility: Sacramento Ear, Nose, & Throat
state: California
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Boca Raton
country: United States
facility: ENT and Allergy Associates of Florida
state: Florida
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Louisville
country: United States
facility: Advanced ENT & Allergy
state: Kentucky
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose & Throat Associates
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
citation: Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
citation: Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.