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

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ClinicalTrials.gov Identifier: NCT03325790
Recruitment Status : Active, not recruiting
First Posted : October 30, 2017
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Tracking Information
First Submitted Date  ICMJE October 4, 2017
First Posted Date  ICMJE October 30, 2017
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE September 28, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
  • 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
  • Efficacy of SPI-1005 on hearing loss [ Time Frame: 12 weeks ]
    Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
  • Efficacy of SPI-1005 on word recognition score [ Time Frame: 12 weeks ]
    Improvement in word recognition score from baseline
  • Efficacy of SPI-1005 on tinnitus [ Time Frame: 12 weeks ]
    Improvement in the Tinnitus Functional Index from baseline
  • Efficacy of SPI-1005 on tinnitus loudness [ Time Frame: 12 weeks ]
    Improvement in Tinnitus Loudness on response to Tinnitus Functional Index Question Number 2
  • Efficacy of SPI-1005 on vertigo [ Time Frame: 12 weeks ]
    Improvement in Vertigo Symptom Scale from baseline
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
  • Safety of SPI-1005 treatment in adults with Meniere's disease: Number and severity of adverse events [ Time Frame: 12 weeks ]
    Number and severity of adverse events in patients treated with placebo versus SPI-1005
  • Efficacy of SPI-1005 on hearing loss: Improvement in sensorineural hearing loss from baseline using pure tone audiometry [ Time Frame: 12 weeks ]
    Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
  • Efficacy of SPI-1005 on word recognition: Improvement in word recognition score [ Time Frame: 12 weeks ]
    Improvement in word recognition score from baseline
  • Efficacy of SPI-1005 on tinnitus: Improvement in the Tinnitus Functional Index [ Time Frame: 12 weeks ]
    Improvement in the Tinnitus Functional Index from baseline
  • Efficacy of SPI-1005 on tinnitus loudness: Improvement in Tinnitus Loudness [ Time Frame: 12 weeks ]
    Improvement in Tinnitus Loudness from baseline
  • Efficacy of SPI-1005 on vertigo: Improvement in Vertigo Symptom Scale [ Time Frame: 12 weeks ]
    Improvement in Vertigo Symptom Scale from baseline
Change History Complete list of historical versions of study NCT03325790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2017)
Maximum Plasma Concentration of SPI-1005 [ Time Frame: 12 weeks ]
Maximum plasma concentration of SPI-1005 will be determined at certain time intervals
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 SPI-1005 for the Treatment of Patients With Meniere's Disease
Official Title  ICMJE A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Meniere's Disease
Intervention  ICMJE
  • Drug: 200mg SPI-1005 BID
    Active: low dose
    Other Name: ebselen
  • Drug: 400mg SPI-1005 BID
    Active: high dose
    Other Name: ebselen
  • Other: Placebo
    Placebo Comparator
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
  • Experimental: 200mg SPI-1005 twice daily (BID)
    200mg SPI-1005 BID
    Intervention: Drug: 200mg SPI-1005 BID
  • Experimental: 400mg SPI-1005 BID
    400mg SPI-1005 BID
    Intervention: Drug: 400mg SPI-1005 BID
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2017)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 NCT03325790
Other Study ID Numbers  ICMJE SPI-1005-251
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sound Pharmaceuticals, Incorporated
Study Sponsor  ICMJE Sound Pharmaceuticals, Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jonathan Kil, MD Sound Pharmaceuticals, Inc.
PRS Account Sound Pharmaceuticals, Incorporated
Verification Date March 2019

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