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

NCT03325790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2023-09-18

Study results available
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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.

Conditions

  • Meniere's Disease

Interventions

DRUG

200mg SPI-1005 BID

Active: low dose

DRUG

400mg SPI-1005 BID

Active: high dose

OTHER

Placebo

Placebo Comparator

Sponsors & Collaborators

  • Sound Pharmaceuticals, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jonathan Kil, MD · Sound Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03325790 on ClinicalTrials.gov