NCT02779192: PANIHL

A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

Withdrawn Phase 2 Last updated 1 June 2026

What this trial tests

Phase 2 trial testing SPI-1005 200mg in Noise Induced Hearing Loss. Withdrawn.

Timeline

1 June 2026

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	Sound Pharmaceuticals, Incorporated
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	1 June 2026
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	5 locations across United States

Drugs / interventions tested

• SPI-1005 200mg — full drug profile →
• SPI-1005 400mg — full drug profile →
• Placebo

Conditions studied

• Noise Induced Hearing Loss — all drugs for Noise Induced Hearing Loss →

Sponsor

Sound Pharmaceuticals, Incorporated — full company profile →

Who can join

Adults 18 to 50, any sex, with Noise Induced Hearing Loss. Healthy volunteers can join.

What's being measured

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

• Reduction in the Incidence of a Significant Threshold Shift
  Time frame: Within 1 day
  Post Controlled Sound Challenge pure tone audiometry will be compared with baseline

Sponsor's own description

SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.

Publications & conference data

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

1. Noise-Induced Hearing Loss.
   Natarajan N, Batts S, Stankovic KM. · · 2023 · cited 115× · PMID 36983347 · DOI 10.3390/jcm12062347
2. Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov.
   Le Prell CG. · · 2021 · cited 18× · PMID 35609594 · DOI 10.1055/s-0041-1735522
3. 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
4. Otoprotectants: From Research to Clinical Application.
   Le Prell CG. · · 2019 · cited 16× · PMID 31036993 · DOI 10.1055/s-0039-1684045
5. 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
6. Prevention of Noise-Induced Hearing Loss Using Investigational Medicines for the Inner Ear: Previous Trial Outcomes Should Inform Future Trial Design.
   Le Prell CG. · · 2022 · cited 12× · PMID 34346254 · DOI 10.1089/ars.2021.0166
7. 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
8. p47phox: A Central Regulator of NADPH Oxidase Function and a Promising Therapeutic Target in Redox-Related Diseases.
   Gamble ME, Sureshkumar S, Carrera Espinoza MJ, Hakim NL, et al · · 2025 · cited 3× · PMID 40710296 · DOI 10.3390/cells14141043