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

Primary Purpose

Meniere's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

SPI-1005

About this trial

This is an interventional treatment trial for Meniere's Disease focused on measuring Meniere's, hearing loss, vertigo, tinnitus, ebselen

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

House Clinic
New York Otology
MUSC
Sound Pharmaceuticals, Inc.
Northwest Ear

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Low dose

Mid dose

High dose

Arm Description

0 mg SPI-1005 bid po x 21d

200 mg SPI-1005 bid po x 21d

400 mg SPI-1005 bid po x 21d

600 mg SPI-1005 bid po x 21d

Outcomes

Primary Outcome Measures

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

Incidence of of Treatment-Emergent Adverse Events

Secondary Outcome Measures

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

Evaluation of potential accumulation of study drug

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

Evaluation of potential changes in plasma selenium levels

Impact on Sensorineural Hearing Loss

Pure Tone Audiometry

Impact on Speech Discrimination

Words in Noise Test

Impact on Tinnitus

Questionnaire

Impact on Vertigo

Questionnaire

Pharmacodynamic response

Electrocochleography

Full Information

NCT ID

NCT02603081

First Posted

November 2, 2015

Last Updated

March 15, 2021

Sponsor

Sound Pharmaceuticals, Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT02603081

Brief Title

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

Official Title

Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sound Pharmaceuticals, Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meniere's Disease

Keywords

Meniere's, hearing loss, vertigo, tinnitus, ebselen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0 mg SPI-1005 bid po x 21d

Arm Title

Low dose

Arm Type

Active Comparator

Arm Description

200 mg SPI-1005 bid po x 21d

Arm Title

Mid dose

Arm Type

Active Comparator

Arm Description

400 mg SPI-1005 bid po x 21d

Arm Title

High dose

Arm Type

Active Comparator

Arm Description

600 mg SPI-1005 bid po x 21d

Intervention Type

Drug

Intervention Name(s)

SPI-1005

Other Intervention Name(s)

ebselen

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Incidence of of Treatment-Emergent Adverse Events

Time Frame

7 weeks

Secondary Outcome Measure Information:

Title

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

Description

Evaluation of potential accumulation of study drug

Time Frame

7 weeks

Title

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

Description

Evaluation of potential changes in plasma selenium levels

Time Frame

7 weeks

Title

Impact on Sensorineural Hearing Loss

Description

Pure Tone Audiometry

Time Frame

7 weeks

Title

Impact on Speech Discrimination

Description

Words in Noise Test

Time Frame

7 weeks

Title

Impact on Tinnitus

Description

Questionnaire

Time Frame

7 weeks

Title

Impact on Vertigo

Description

Questionnaire

Time Frame

7 weeks

Title

Pharmacodynamic response

Description

Electrocochleography

Time Frame

7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Kil, MD

Organizational Affiliation

Sound Pharmaceuticals

Official's Role

Study Chair

Facility Information:

Facility Name

House Clinic

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

New York Otology

City

New York

State/Province

New York

ZIP/Postal Code

10028

Country

United States

Facility Name

MUSC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Sound Pharmaceuticals, Inc.

City

Seattle

State/Province

Washington

ZIP/Postal Code

98103

Country

United States

Facility Name

Northwest Ear

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17030476

Citation

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.

Results Reference

background

Citation

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.

Results Reference

background

PubMed Identifier

33678494

Citation

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.

Results Reference

background

PubMed Identifier

32483557

Citation

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.

Results Reference

derived

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

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