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A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

Primary Purpose

Noise Induced Hearing Loss

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

SPI-1005 200mg

SPI-1005 400mg

Placebo

About this trial

This is an interventional treatment trial for Noise Induced Hearing Loss focused on measuring Acute Noise Induced Hearing Loss, Prevent Acute Noise Induced Hearing Loss

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult male or female patients, 18-50 years of age
History of either recreational and/or occupational exposure to noise
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 intra-uterine device 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 60 days prior to study of excluded ototoxic medications
History of autoimmune inner ear disease
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

University of Miami
University of Kansas Medical Center
MUSC
University of Texas Southwestern
Sound Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

SPI-1005 200 mg

SPI-1005 400 mg

Placebo

Arm Description

200 mg SPI-1005, capsule, bid, po, x7d

400 mg SPI-1005, capsule, bid, po, x7d

0 mg SPI-1005, capsule, bid, po, x7d

Outcomes

Primary Outcome Measures

Reduction in the Incidence of a Significant Threshold Shift

Post Controlled Sound Challenge pure tone audiometry will be compared with baseline

Secondary Outcome Measures

Improvement in word recognition score

Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline

Full Information

NCT ID

NCT02779192

First Posted

May 18, 2016

Last Updated

August 22, 2018

Sponsor

Sound Pharmaceuticals, Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT02779192

Brief Title

A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss

Acronym

PANIHL

Official Title

A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2018 (Anticipated)

Primary Completion Date

June 2021 (Anticipated)

Study Completion Date

October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sound Pharmaceuticals, Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.

Detailed Description

Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.

6. Conditions and Keywords

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

Noise Induced Hearing Loss

Keywords

Acute Noise Induced Hearing Loss, Prevent Acute Noise Induced Hearing Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SPI-1005 200 mg

Arm Type

Active Comparator

Arm Description

200 mg SPI-1005, capsule, bid, po, x7d

Arm Title

SPI-1005 400 mg

Arm Type

Active Comparator

Arm Description

400 mg SPI-1005, capsule, bid, po, x7d

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0 mg SPI-1005, capsule, bid, po, x7d

Intervention Type

Drug

Intervention Name(s)

SPI-1005 200mg

Other Intervention Name(s)

Low Dose

Intervention Description

Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days

Intervention Type

Drug

Intervention Name(s)

SPI-1005 400mg

Other Intervention Name(s)

High Dose

Intervention Description

Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days

Primary Outcome Measure Information:

Title

Reduction in the Incidence of a Significant Threshold Shift

Description

Post Controlled Sound Challenge pure tone audiometry will be compared with baseline

Time Frame

Within 1 day

Secondary Outcome Measure Information:

Title

Improvement in word recognition score

Description

Post Controlled Sound Challenge Words in Noise Test score will be compared with baseline

Time Frame

Within 1 day

Other Pre-specified Outcome Measures:

Title

Adverse events

Description

Adverse events due to study drug will be compared with placebo

Time Frame

Within 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult male or female patients, 18-50 years of age History of either recreational and/or occupational exposure to noise 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 intra-uterine device 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 60 days prior to study of excluded ototoxic medications History of autoimmune inner ear disease 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan Kil, MD

Phone

2066342559

jkil@soundpharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Kil, MD

Organizational Affiliation

SOUND PHARMACEUTICALS, INC.

Official's Role

Study Chair

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Hoffer, MD

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66103

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hinrich Staecker, MD/PhD

Facility Name

MUSC

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

University of Texas Southwestern

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joe Kutz, MD

Facility Name

Sound Pharmaceuticals, Inc.

City

Seattle

State/Province

Washington

ZIP/Postal Code

98103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss

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