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Study to Evaluate SPI-1005 in Adults With Meniere's Disease

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier:
NCT02603081
First received: November 2, 2015
Last updated: June 9, 2016
Last verified: June 2016
  Purpose
This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Condition Intervention Phase
Meniere's Disease
Drug: SPI-1005
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease

Resource links provided by NLM:


Further study details as provided by Sound Pharmaceuticals, Incorporated:

Primary Outcome Measures:
  • Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures. [ Time Frame: 7 weeks ]
    Incidence of of Treatment-Emergent Adverse Events


Secondary Outcome Measures:
  • Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing [ Time Frame: 7 weeks ]
    Evaluation of potential accumulation of study drug

  • Plasma Selenium levels before, during, and after 21 days of dosing [ Time Frame: 7 weeks ]
    Evaluation of potential changes in plasma selenium levels

  • Impact on Sensorineural Hearing Loss [ Time Frame: 7 weeks ]
    Pure Tone Audiometry

  • Impact on Speech Discrimination [ Time Frame: 7 weeks ]
    Words in Noise Test

  • Impact on Tinnitus [ Time Frame: 7 weeks ]
    Questionnaire

  • Impact on Vertigo [ Time Frame: 7 weeks ]
    Questionnaire

  • Pharmacodynamic response [ Time Frame: 7 weeks ]
    Electrocochleography


Estimated Enrollment: 40
Study Start Date: December 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
0 mg SPI-1005 bid po x 21d
Drug: SPI-1005
Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Other Name: ebselen
Active Comparator: Low dose
200 mg SPI-1005 bid po x 21d
Drug: SPI-1005
Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Other Name: ebselen
Active Comparator: Mid dose
400 mg SPI-1005 bid po x 21d
Drug: SPI-1005
Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Other Name: ebselen
Active Comparator: High dose
600 mg SPI-1005 bid po x 21d
Drug: SPI-1005
Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
Other Name: ebselen

Detailed Description:
Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment;
  • Voluntarily consent to participate in the study;
  • Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:

    • Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or
    • IUD in place for at least 3 months prior to study through study completion; 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 through study completion; or
    • Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
  • Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.

Exclusion Criteria:

  • Current use or within 90 days prior to study of ototoxic medications such as aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide);
  • History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma;
  • History of middle ear or inner ear surgery;
  • Current conductive hearing loss or middle ear effusion;
  • Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease;
  • History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen;
  • Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes;
  • Participation in another investigational drug or device study within 90 days prior to study enrollment;
  • Female patients who are pregnant or breastfeeding.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02603081

Locations
United States, California
House Clinic
Los Angeles, California, United States, 90057
United States, New York
New York Otology
New York, New York, United States, 10028
United States, South Carolina
MUSC
Charleston, South Carolina, United States, 29425
United States, Washington
Sound Pharmaceuticals, Inc.
Seattle, Washington, United States, 98103
Northwest Ear
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
Investigators
Study Chair: Jonathan Kil, MD Sound Pharmaceuticals
  More Information

Publications:
Lynch E, Kil J. Development of ebselen, a glutathione peroxidase mimic, for the prevention and treatment of noise-induced hearing loss. Semin Hear 2009; 30(1):47-55.

Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT02603081     History of Changes
Other Study ID Numbers: SPI-1005-151 
Study First Received: November 2, 2015
Last Updated: June 9, 2016

Keywords provided by Sound Pharmaceuticals, Incorporated:
Meniere's
hearing loss
vertigo
tinnitus
ebselen

Additional relevant 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

ClinicalTrials.gov processed this record on February 27, 2017