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

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ClinicalTrials.gov Identifier: NCT02603081
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Tracking Information
First Submitted Date  ICMJE November 2, 2015
First Posted Date  ICMJE November 11, 2015
Last Update Posted Date October 2, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures. [ Time Frame: 7 weeks ]
Incidence of of Treatment-Emergent Adverse Events
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02603081 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate SPI-1005 in Adults With Meniere's Disease
Official Title  ICMJE Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Meniere's Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    0 mg SPI-1005 bid po x 21d
    Intervention: Drug: SPI-1005
  • Active Comparator: Low dose
    200 mg SPI-1005 bid po x 21d
    Intervention: Drug: SPI-1005
  • Active Comparator: Mid dose
    400 mg SPI-1005 bid po x 21d
    Intervention: Drug: SPI-1005
  • Active Comparator: High dose
    600 mg SPI-1005 bid po x 21d
    Intervention: Drug: SPI-1005
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02603081
Other Study ID Numbers  ICMJE SPI-1005-151
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sound Pharmaceuticals, Incorporated
Study Sponsor  ICMJE Sound Pharmaceuticals, Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jonathan Kil, MD Sound Pharmaceuticals
PRS Account Sound Pharmaceuticals, Incorporated
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP