SPI-1005 for the Treatment of Meniere's Disease

Meniere Disease Clinical Trial

— STOPMD-3  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04677972
• Other study ID #: SPI-1005-351
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Sound Pharmaceuticals, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 254
• Est. completion date: August 2024
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ménière
• Meniere Disease

Intervention

Drug:
• Ebselen
Glutathione peroxidase mimetic
• Placebo
Matching placebo containing excipients

Locations

Country	Name	City	State
United States	ENT and Allergy Associates of Florida	Boca Raton	Florida
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Indiana University	Indianapolis	Indiana
United States	Kansas University Medical Center	Kansas City	Kansas
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	House Clinic	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Advanced ENT & Allergy	Louisville	Kentucky
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Sacramento Ear, Nose, & Throat	Roseville	California
United States	George Washington University	Washington	District of Columbia
United States	Piedmont Ear, Nose & Throat Associates	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sound Pharmaceuticals, Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Safety and tolerability assessed based on comparison of adverse events vs. placebo	84 days
Primary	Change in low frequency hearing thresholds measured by pure tone audiometry	Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry	56 days
Primary	Change in Words-in-Noise Test score	Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test	56 days
Secondary	Change in tinnitus severity	Tinnitus Functional Index (0-100) where higher score is worse outcome	56 days
Secondary	Change in tinnitus loudness	Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome	56 days
Secondary	Change in vertigo severity	Vertigo Symptom Scale (0-60) where higher score is worse outcome	56 days
Secondary	Change in aural fullness	Aural Fullness Scale (0-10) where higher score is worse outcome	56 days
Secondary	Change in dizziness	Dizziness Handicap Inventory (0-100) where higher score is worse outcome	56 days