NCT02603081 is a Phase 1/Phase 2 clinical trial of SPI-1005 in Meniere's Disease, sponsored by Sound Pharmaceuticals, Incorporated.

Who is sponsoring NCT02603081?

NCT02603081 is sponsored by Sound Pharmaceuticals, Incorporated.

What drugs are being tested in NCT02603081?

Interventions in NCT02603081: SPI-1005.

What condition does NCT02603081 study?

NCT02603081 studies Meniere's Disease.

Is NCT02603081 still recruiting?

NCT02603081 is currently completed. Last updated 15 March 2021.

Last reviewed 2021-03-15 · How we verify

NCT02603081

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease

Completed Phase 1/Phase 2 Last updated 15 March 2021

What this trial tests

Phase 1/Phase 2 trial testing SPI-1005 in Meniere's Disease in 40 participants. Completed in 1 August 2017.

Timeline

1 December 2015

Primary endpoint
1 August 2017

1 August 2017

Quick facts

Lead sponsor	Sound Pharmaceuticals, Incorporated
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 December 2015
Primary completion	1 August 2017
Estimated completion	1 August 2017
Sites	5 locations across United States

Drugs / interventions tested

SPI-1005 — full drug profile →

Conditions studied

Meniere's Disease — all drugs for Meniere's Disease →

Sponsor

Sound Pharmaceuticals, Incorporated — full company profile →

Who can join

Adults 19 to 70, any sex, with Meniere's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.
Time frame: 7 weeks
Incidence of of Treatment-Emergent Adverse Events

Sponsor's own description

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting oxidative stress in disease: promise and limitations of antioxidant therapy.
Forman HJ, Zhang H. · · 2021 · cited 1789× · PMID 34194012 · DOI 10.1038/s41573-021-00233-1
The Clinical Drug Ebselen Attenuates Inflammation and Promotes Microbiome Recovery in Mice after Antibiotic Treatment for CDI.
Garland M, Hryckowian AJ, Tholen M, Bender KO, et al · · 2020 · cited 37× · PMID 32483557 · DOI 10.1016/j.xcrm.2020.100005
Selenium-Containing Agents Acting on Cancer-A New Hope?
Garbo S, Di Giacomo S, Łażewska D, Honkisz-Orzechowska E, et al · · 2022 · cited 29× · PMID 36678733 · DOI 10.3390/pharmaceutics15010104
Recent Therapeutic Progress and Future Perspectives for the Treatment of Hearing Loss.
Lye J, Delaney DS, Leith FK, Sardesai VS, et al · · 2023 · cited 16× · PMID 38137568 · DOI 10.3390/biomedicines11123347
Covalent Modifiers of Botulinum Neurotoxin Counteract Toxin Persistence.
Garland M, Babin BM, Miyashita SI, Loscher S, et al · · 2019 · cited 13× · PMID 30571080 · DOI 10.1021/acschembio.8b00937
Unveiling the Role of Oxidative Stress in Cochlear Hair Cell Death: Prospective Phytochemical Therapeutics against Sensorineural Hearing Loss.
Gill NB, Dowker-Key PD, Hedrick M, Bettaieb A. · · 2024 · cited 9× · PMID 38673858 · DOI 10.3390/ijms25084272
Insights on Localized and Systemic Delivery of Redox-Based Therapeutics.
Buglak NE, Batrakova EV, Mota R, Bahnson ESM. · · 2018 · cited 9× · PMID 29636836 · DOI 10.1155/2018/2468457
Oxidative stress responses in <i>Ehrlichia</i>-induced sepsis: mechanisms and implications in pathogenesis.
Sharma AK, Ismail N. · · 2025 · cited 1× · PMID 40488533 · DOI 10.1128/mbio.00499-25

Verify or expand the search:

Other recruiting trials for Meniere's Disease

Currently open trials in the same condition.

NCT07518069 — Genetic and Biohumoral Factors Involved in Menière's Disease and Their Correlation With Phenotypes · recruiting
NCT03587701 — Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Dise · Phase 2 · recruiting

Other Sound Pharmaceuticals, Incorporated trials

Trials by the same sponsor.

NCT04677972 — SPI-1005 for the Treatment of Meniere's Disease · Phase 3 · completed
NCT04484025 — SPI-1005 Treatment in Moderate COVID-19 Patients · Phase 2 · unknown
NCT04483973 — SPI-1005 Treatment in Severe COVID-19 Patients · Phase 2 · unknown
NCT01451853 — SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss · Phase 2 · unknown
NCT03325790 — SPI-1005 for the Treatment of Patients With Meniere's Disease · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02603081 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sound Pharmaceuticals, Incorporated
Last refreshed: 15 March 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02603081.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing