NCT03325790

SPI-1005 for the Treatment of Patients With Meniere's Disease

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Sound Pharmaceuticals, Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.

Detailed description

Study participants will be randomized to SPI-1005 or placebo in this double-blind study to evaluate both safety and efficacy of the investigational treatment. Participants, aged 18-75 years, with probable or definite Meniere's disease will undergo baseline testing to assess severity of sensorineural hearing loss, tinnitus and vertigo. During the study, and 28 days after completion of treatment, participants will be evaluated for safety (adverse events, physical examinations, vital signs and clinical laboratory testing (CBC,serum chemistry). Trough plasma levels of ebselen and its major metabolite will be determined using liquid chromatography-mass spectrometry (LCMS) at specified visits. Additionally, plasma will be analyzed for selenium at the corresponding visits. The effect of SPI-1005 on hearing and balance will be evaluated. Tinnitus (TFI) and vertigo (VSS) will be evaluated at baseline, during and study treatment.

Conditions

• Meniere's Disease

Interventions

Type	Name	Description
DRUG	200mg SPI-1005 BID	Active: low dose
DRUG	400mg SPI-1005 BID	Active: high dose
OTHER	Placebo	Placebo Comparator

Timeline

• Start date: 2017-09-28
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2017-10-30
• Last updated: 2023-09-18
• Results posted: 2023-08-14

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study