NCT02603081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

1.7 years

First QC Date

November 2, 2015

Last Update Submit

March 15, 2021

Conditions

Meniere's Disease

Keywords

Meniere'shearing lossvertigotinnitusebselen

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.

    Incidence of of Treatment-Emergent Adverse Events

    7 weeks

Secondary Outcomes (7)

  • Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing

    7 weeks

  • Plasma Selenium levels before, during, and after 21 days of dosing

    7 weeks

  • Impact on Sensorineural Hearing Loss

    7 weeks

  • Impact on Speech Discrimination

    7 weeks

  • Impact on Tinnitus

    7 weeks

  • +2 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

0 mg SPI-1005 bid po x 21d

Drug: SPI-1005

Low dose

ACTIVE COMPARATOR

200 mg SPI-1005 bid po x 21d

Drug: SPI-1005

Mid dose

ACTIVE COMPARATOR

400 mg SPI-1005 bid po x 21d

Drug: SPI-1005

High dose

ACTIVE COMPARATOR

600 mg SPI-1005 bid po x 21d

Drug: SPI-1005

Interventions

SPI-1005DRUG

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.

Also known as: ebselen
High doseLow doseMid dosePlacebo

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

House Clinic

Los Angeles, California, 90057, United States

Location

New York Otology

New York, New York, 10028, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

Sound Pharmaceuticals, Inc.

Seattle, Washington, 98103, United States

Location

Northwest Ear

Seattle, Washington, 98104, United States

Location

Related Publications (4)

  • Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.

    PMID: 17030476BACKGROUND

  • 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.

    BACKGROUND

  • Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.

    PMID: 33678494BACKGROUND

  • Garland M, Hryckowian AJ, Tholen M, Bender KO, Van Treuren WW, Loscher S, Sonnenburg JL, Bogyo M. The Clinical Drug Ebselen Attenuates Inflammation and Promotes Microbiome Recovery in Mice after Antibiotic Treatment for CDI. Cell Rep Med. 2020 Apr 21;1(1):100005. doi: 10.1016/j.xcrm.2020.100005.

    PMID: 32483557DERIVED

MeSH Terms

Conditions

Meniere DiseaseHearing LossVertigoTinnitus

Interventions

ebselen

Condition Hierarchy (Ancestors)

Endolymphatic HydropsLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVestibular Diseases

Study Officials

  • Jonathan Kil, MD

    Sound Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 11, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

US(5)