STOPMD-3: SPI-1005 for the Treatment of Meniere's Disease

Sponsor

Sound Pharmaceuticals, Incorporated (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04677972

Collaborator

(none)

200

Enrollment

Locations

Arms

Anticipated Duration (Months)

10.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meniere Disease Ménière	Drug: Ebselen Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPI-1005 400 mg BID Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup	Drug: Ebselen Glutathione peroxidase mimetic Other Names: SPI-1005
Placebo Comparator: Placebo Oral administration of matching placebo BID for 28 days, with 84-day followup	Drug: Placebo Matching placebo containing excipients

Arm

Intervention/Treatment

Experimental: SPI-1005 400 mg BID

Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup

Drug: Ebselen

Glutathione peroxidase mimetic

Other Names:

SPI-1005

Placebo Comparator: Placebo

Oral administration of matching placebo BID for 28 days, with 84-day followup

Drug: Placebo

Matching placebo containing excipients

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [84 days]
Safety and tolerability assessed based on comparison of adverse events vs. placebo
Change in low frequency hearing thresholds measured by pure tone audiometry [56 days]
Co-primary efficacy endpoint; assessment of hearing by pure tone audiometry
Change in Words-in-Noise Test score [56 days]
Co-primary efficacy endpoint; assessment of word recognition by Words-in-Noise Test

Secondary Outcome Measures

Change in tinnitus severity [56 days]
Tinnitus Functional Index (0-100) where higher score is worse outcome
Change in tinnitus loudness [56 days]
Tinnitus Functional Index Question #2 -- How Strong or Loud was your Tinnitus? (0-10) where higher score is worse outcome
Change in vertigo severity [56 days]
Vertigo Symptom Scale (0-60) where higher score is worse outcome
Change in aural fullness [56 days]
Aural Fullness Scale (0-10) where higher score is worse outcome
Change in dizziness [56 days]
Dizziness Handicap Inventory (0-100) where higher score is worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas for Medical Sciences	Little Rock	Arkansas	United States	72205
2	University of California Irvine	Irvine	California	United States	92604
3	University of Southern California	Los Angeles	California	United States	90033
4	House Clinic	Los Angeles	California	United States	90057
5	Sacramento Ear, Nose, & Throat	Roseville	California	United States	95661
6	University of California San Francisco	San Francisco	California	United States	94115
7	George Washington University	Washington	District of Columbia	United States	20037
8	Georgetown University	Washington	District of Columbia	United States	20057
9	University of Miami	Miami	Florida	United States	33146
10	Indiana University	Indianapolis	Indiana	United States	46202
11	Kansas University Medical Center	Kansas City	Kansas	United States	66160
12	Advanced ENT & Allergy	Louisville	Kentucky	United States	40207
13	Washington University in St. Louis	Saint Louis	Missouri	United States	63130
14	Mount Sinai Hospital	New York	New York	United States	10010
15	Columbia University Medical Center	New York	New York	United States	10032
16	Piedmont Ear, Nose & Throat Associates	Winston-Salem	North Carolina	United States	27103
17	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19144
18	Medical University of South Carolina	Charleston	South Carolina	United States	29425
19	UT Southwestern	Dallas	Texas	United States	75390