Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03325790
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: 200mg SPI-1005 BID Drug: 400mg SPI-1005 BID Other: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: DOUBLE-BLIND
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Other: Placebo
Placebo Comparator

Experimental: 200mg SPI-1005 twice daily (BID)
200mg SPI-1005 BID
Drug: 200mg SPI-1005 BID
Active: low dose
Other Name: ebselen

Experimental: 400mg SPI-1005 BID
400mg SPI-1005 BID
Drug: 400mg SPI-1005 BID
Active: high dose
Other Name: ebselen




Primary Outcome Measures :
  1. Safety of SPI-1005 treatment in adults with Meniere's disease [ Time Frame: 12 weeks ]
    Number and severity of adverse events in patients treated with placebo versus SPI-1005

  2. Efficacy of SPI-1005 on hearing loss [ Time Frame: 12 weeks ]
    Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry

  3. Efficacy of SPI-1005 on word recognition score [ Time Frame: 12 weeks ]
    Improvement in word recognition score from baseline

  4. Efficacy of SPI-1005 on tinnitus [ Time Frame: 12 weeks ]
    Improvement in the Tinnitus Functional Index from baseline

  5. Efficacy of SPI-1005 on tinnitus loudness [ Time Frame: 12 weeks ]
    Improvement in Tinnitus Loudness on response to Tinnitus Functional Index Question Number 2

  6. Efficacy of SPI-1005 on vertigo [ Time Frame: 12 weeks ]
    Improvement in Vertigo Symptom Scale from baseline


Secondary Outcome Measures :
  1. Maximum Plasma Concentration of SPI-1005 [ Time Frame: 12 weeks ]
    Maximum plasma concentration of SPI-1005 will be determined at certain time intervals



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, carboplatinum, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325790


Locations
Layout table for location information
United States, California
Ccent/Cccr
Fresno, California, United States, 93720
UCSD
San Diego, California, United States, 92093
UCSF
San Francisco, California, United States, 94115
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20057
United States, Florida
UMiami
Miami, Florida, United States, 33146
United States, Kansas
KUMC
Kansas City, Kansas, United States, 66160
United States, Kentucky
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
United States, New York
ENT and Allergy Associates, LLP
New York, New York, United States, 10017
United States, North Carolina
CEENTA
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
TJU
Philadelphia, Pennsylvania, United States, 19144
United States, South Carolina
MUSC
Charleston, South Carolina, United States, 29425
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
United States, Washington
Northwest Ear, Inc.
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
Investigators
Layout table for investigator information
Study Chair: Jonathan Kil, MD Sound Pharmaceuticals, Inc.

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT03325790     History of Changes
Other Study ID Numbers: SPI-1005-251
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sound Pharmaceuticals, Incorporated:
Meniere's disease
Hearing Loss
Vertigo
Tinnitus
Ebselen
Pharmacokinetics
Safety
Efficacy
Speech

Additional relevant MeSH terms:
Layout table for MeSH terms
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Ebselen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents