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

August 21, 2023 updated by: Sound Pharmaceuticals, Incorporated

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Fresno, California, United States, 93720
        • Ccent/Cccr
      • San Diego, California, United States, 92093
        • UCSD
      • San Francisco, California, United States, 94115
        • UCSF
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University
    • Florida
      • Miami, Florida, United States, 33146
        • UMiami
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • KUMC
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Advanced ENT & Allergy
    • New York
      • New York, New York, United States, 10017
        • ENT and Allergy Associates, LLP
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • CEENTA
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19144
        • TJU
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
    • Washington
      • Seattle, Washington, United States, 98104
        • Northwest Ear, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult male and female patients, 18-75 years of age at the time of enrollment.
  • Diagnosis of probable or definitive Meniere's disease by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) 1995 criteria.
  • Two of three active symptoms including vertigo or disequilibrium, fluctuating hearing loss, or tinnitus within the 3 months prior to study enrollment.
  • Hearing loss of ≥ 30 decibels (dBHL) at either 250, 500 or 1000 Hz.
  • Voluntary consent to participate in the study.
  • Male subjects that are willing to use condoms throughout the study period and 90-days following study completion even if not fertile.
  • Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:

    • Intrauterine Device in place for at least 3 months prior to study; or
    • Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or
    • Stable hormonal contraceptive for at least 3 months prior to study and through study completion; or
    • Surgical sterilization (vasectomy) of partner at least 6 months prior to study enrollment.
  • Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study enrollment, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 1 year since last menses.

Exclusion Criteria:

  • Current use of or within 60 days prior to study IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
  • History of otosclerosis or vestibular schwannoma.
  • History of significant middle ear or inner ear surgery.
  • Current conductive hearing loss, otitis media, or mixed hearing loss.
  • Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease.
  • Current use or within 30 days prior to study enrollment systemic steroids or drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes.
  • Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or selenium.
  • Female patients who are pregnant or breastfeeding.
  • Participation in another interventional drug or device study within 30 days prior to study consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Comparator
Experimental: 200mg SPI-1005 twice daily (BID)
200mg SPI-1005 BID
Active: low dose
Other Names:
  • ebselen
Experimental: 400mg SPI-1005 BID
Active: high dose
Other Names:
  • ebselen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of SPI-1005 on Hearing Loss
Time Frame: 8 weeks
Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
8 weeks
Efficacy of SPI-1005 on Word Recognition Score
Time Frame: 8 weeks
Improvement in Words-in-Noise (WIN) test score from baseline. WIN test score, 0-35 words, in which a higher score means a better outcome.
8 weeks
Efficacy of SPI-1005 on Tinnitus
Time Frame: 8 weeks
Improvement in the Tinnitus Functional Index (TFI) from baseline. TFI Total Score: 0-100, in which a higher score means a worse outcome.
8 weeks
Efficacy of SPI-1005 on Tinnitus Loudness
Time Frame: 8 weeks

Improvement in Tinnitus Loudness (TL) on response to Tinnitus Functional Index Question Number 2.

Question Number 2: "How Strong or Loud is your tinnitus?": 0-10, in which a higher score means a worse outcome.

8 weeks
Efficacy of SPI-1005 on Vertigo
Time Frame: 8 weeks
Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome
8 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time Frame: 8 weeks

Number and severity of adverse events in patients treated with placebo versus SPI-1005.

Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting.

8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Plasma Concentration of SPI-1005
Time Frame: 2 weeks, 4 weeks, 8 weeks
Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals
2 weeks, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jonathan Kil, MD, Sound Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2017

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 27, 2017

First Posted (Actual)

October 30, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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